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Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER). (micSPIDER)

4. september 2026 opdateret af: Centre Hospitalier Universitaire de Nīmes

Inflammatory Skin Diseases of Skin Folds and Perioral Areas (SPIDER) in Patients With Chronic Inflammatory Bowel Disease on Anti-TNFα Therapy: Characterization of the Staphylococcus Aureus Population Within the Lesion Microbiota and Correlation With Clinical Findings

The main objective of this study is to evaluate the change in the relative abundance of S. aureus within the lesion-site skin microbiota in SPIDER patients (change between inclusion and 6 months), and to assess whether this change in S. aureus abundance is associated with a favorable (or unfavorable) evolution of the wounds over the same period.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Detaljeret beskrivelse

Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), affect around 2.5 million people worldwide, including 300,000 in France. These conditions mainly impact young adults and follow a relapsing-remitting course with significant morbidity. CD is a chronic, debilitating disease caused by complex interactions among genetic, environmental, and microbiota-related factors, leading to transmural inflammation of the digestive tract and both intestinal and extra-intestinal symptoms. UC affects the mucosa of the colon and rectum, with similar gastrointestinal symptoms and frequent cutaneous, ocular, and rheumatologic manifestations.

Treatment aims for deep remission and relies largely on anti-TNFα therapies, complemented by other drugs or surgery; newer biologics like vedolizumab and ustekinumab are also used. However, anti-TNFα-treated patients often develop cutaneous comorbidities, such as psoriasis, granulomatous lesions, or neutrophilic dermatoses. A significant proportion also develop skin infections, commonly due to Staphylococcus aureus. One study reported inflammatory skin lesions in 40% of IBD patients on anti-TNFα, with S. aureus nasal or cutaneous carriage frequently associated. The precise relationship between S. aureus and these lesions, however, remains unclear.

Description of the treatment/strategy/procedure: Swabbing of healthy areas and lesion sites will be performed in the same way in the SPIDER+ and SPIDER- groups at Day 0 (D0). Microbiota sequencing and cultures will be carried out under the same conditions in both groups.

Description of follow-up: SPIDER+ patients will be recruited from the dermatology departments of the participating university hospitals (CHUs), notably in Montpellier, Millau, and Béziers. They will receive follow-up over a 12-month period, with an inclusion visit followed by two follow-up visits at 6 and 12 months. On the other hand, for SPIDER- patients a follow-up visit will take place at 12 months, in order to record adverse effects of the treatment (anti-TNF).

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
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Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
    • Aveyron
      • Millau, Aveyron, Frankrig, 12100
        • Centre Hospitalier de MILLAU
        • Kontakt:
        • Ledende efterforsker:
          • Ariane FIZAZI, Dr.
    • Gard
      • Nîmes, Gard, Frankrig, 30029
        • Nîmes University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Natacha CATTEAU, Dr.
        • Underforsker:
          • Blanche BERGERET, Dr.
        • Underforsker:
          • Ludovic CAILLO, Dr.
        • Underforsker:
          • Myriam MARQUE, Dr.
    • Hérault
      • Béziers, Hérault, Frankrig, 34500
        • CHU de Béziers
        • Kontakt:
          • Louise GUILLON, Dr.
        • Ledende efterforsker:
          • Louise GUILLON, Dr.
        • Underforsker:
          • Mohamed BEJAOUI, Dr.
      • Montpellier, Hérault, Frankrig, 34090
        • CHU de Montpellier, Hôpital Arnaud de Villeneuve
        • Kontakt:
        • Ledende efterforsker:
          • Grégoire LAVAUD, Dr.
        • Underforsker:
          • Yasmine JERIDI, Dr.
        • Underforsker:
          • Margot MIGNOT, Dr.
        • Underforsker:
          • Laura KOLLEN, Dr.
      • Montpellier, Hérault, Frankrig, 34090
        • Montpellier University Hospital, Saint Eloi
        • Underforsker:
          • Romain ALTWEGG
        • Kontakt:
        • Ledende efterforsker:
          • Aurélie DU THANH
        • Underforsker:
          • Anne BOZON
        • Underforsker:
          • Lucile BOIVINEAU

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult or pediatric patient (>4 years old), diagnosed with IBD and receiving anti-TNFα therapy, with skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)

Beskrivelse

Inclusion Criteria:

  • Diagnosed with IBD
  • Receiving anti-TNFα therapy
  • WITH skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
  • Parental consent for minor patients
  • Patient who has provided free and informed consent and has signed the consent form
  • Patient affiliated to or beneficiary of a health insurance system

Exclusion Criteria:

  • Patients for whom a change in therapy is planned within 6 months (SPIDER+).
  • Patients receiving antibiotics (systemic or topical) at the time of enrollment, with a window of at least 1 month.
  • Patients who have participated in a clinical drug trial within the last three months
  • Patients currently in an exclusion period determined by a previous study
  • Patients under legal guardianship, conservatorship, or trusteeship
  • Patients who refuse to sign the informed consent form
  • Pregnant or breastfeeding patients.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
SPIDER+ group
Patients diagnosed with IBD receiving anti-TNFα therapy with skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
SPIDER- group (control group):
Patients diagnosed with IBD receiving anti-TNFα therapy for more than 1 year, WITHOUT dermatological lesions suggestive of SPIDER

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative abundance of S. aureus in the SPIDER+ group
Tidsramme: Month 0, baseline
Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions
Month 0, baseline
Relative abundance of S. aureus in the control group
Tidsramme: Month 0, baseline
Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from healthy areas
Month 0, baseline
Relative abundance of S. aureus in the SPIDER+ group
Tidsramme: Month 6
Number of read sequences corresponding to S. aureus divided by the total number of read sequences (%) assessed after sequencing swabs from SPIDER lesions
Month 6
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Tidsramme: Month 0, baseline

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score.

The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.
Month 0, baseline
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Tidsramme: Month 6

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator).The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score.

The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.
Month 6
Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Tidsramme: Month 0, baseline
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life. It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30. Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
Month 0, baseline
Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Tidsramme: Month 6
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life. It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30. Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
Month 6

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Tidsramme: Month 0, baseline

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score.

The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.
Month 0, baseline
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Tidsramme: Month 12

The Physician's Global Assessment score is a clinical scale widely used in dermatology to assess the overall severity of a skin condition. Since there is no specific score for these lesions, it is the only one that can be used. The Physician's Global Assessment score is a global visual assessment of the severity of skin lesions, performed by a healthcare professional (investigator). The Physician's Global Assessment score is an ordinal scale, typically ranging from 0 to 5. A common goal in studies is to achieve a Physician's Global Assessment score of 0 or 1 (resolved or minimal), often with an improvement of at least 2 points from the baseline score.

The Physician's Global Assessment is often used as an endpoint in dermatological clinical trials. It is always combined with a quality-of-life score.
Month 12
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Tidsramme: Month 0, baseline
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life. It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30. Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
Month 0, baseline
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Tidsramme: Month 12
The Dermatology Quality of Life Index is a standardized, validated, and widely used questionnaire designed to assess the impact of a dermatological condition on a patient's quality of life. It consists of 10 questions, each scored from 0 to 3 points, for a total score ranging from 0 to 30. Topics covered include: symptoms and feelings, discomfort, daily activities, and personal relationships.The optimal goal is a maximum score of 5 points or a reduction of at least 4 points compared to baseline (M0).
Month 12
Relative abundance of species found in the experimental group (SPIDER+ patients)
Tidsramme: Month 0, baseline
Relative abundances (in %) of each bacterial species, calculation of alpha diversity (Shannon index) and beta diversity (Bray-Curtis index) following sequencing of swabs taken from lesions at M0, M6, and M12 in SPIDER+ patients.
Month 0, baseline
Relative abundance of species found in the experimental group (SPIDER+ patients)
Tidsramme: Month 6
Relative abundances (in %) of each bacterial species, calculation of alpha diversity (Shannon index) and beta diversity (Bray-Curtis index) following sequencing of swabs taken from lesions at M0, M6, and M12 in SPIDER+ patients.
Month 6
Relative abundance of species found in the experimental group (SPIDER+ patients)
Tidsramme: Month 12
Relative abundances (in %) of each bacterial species, calculation of alpha diversity (Shannon index) and beta diversity (Bray-Curtis index) following sequencing of swabs taken from lesions at M0, M6, and M12 in SPIDER+ patients.
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Tidsramme: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Tidsramme: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Tidsramme: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Tidsramme: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Tidsramme: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Tidsramme: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Tidsramme: Month 0, baseline
Yes/No
Month 0, baseline
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Tidsramme: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Tidsramme: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Tidsramme: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Tidsramme: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Tidsramme: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Tidsramme: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Tidsramme: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Tidsramme: Month 12
In %
Month 12
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Tidsramme: Month 6

A "favorable" change in the lesion at Month12 will be defined as:

a decrease of at least 2 points in the Physician's Global Assessment score (0-5, wherein 0 indicates improvement and 5 indicates worsening) compared to M0, or a Physician's Global Assessment score of 1 or less.
Month 6
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Tidsramme: Month 12

A "favorable" change in the lesion at Month12 will be defined as:

a decrease of at least 2 points in the Physician's Global Assessment score (0-5, wherein 0 indicates improvement and 5 indicates worsening) compared to Month 0, or a Physician's Global Assessment score of 1 or less.
Month 12
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Tidsramme: Month 6
A "favorable" change in the lesion at Month12 will be defined as: an optimal target of up to 5 points or a reduction of at least 4 points compared to Month 0.
Month 6
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Tidsramme: Month 12
A "favorable" change in the lesion at Month12 will be defined as: an optimal target of up to 5 points or a reduction of at least 4 points compared to Month 0.
Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Tidsramme: Month 0, baseline
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Tidsramme: Month 6
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Tidsramme: Month 12
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Tidsramme: Month 0, baseline
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Tidsramme: Month 6
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Tidsramme: Month 12
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Tidsramme: Month 0, baseline
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Tidsramme: Month 6
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Tidsramme: Month 12
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Tidsramme: Month 0, baseline
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Tidsramme: Month 6
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Tidsramme: Month 12
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 12
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Tidsramme: Month 0, baseline
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 0, baseline
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Tidsramme: Month 6
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 6
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Tidsramme: Month 12
Score/5: 1 point for each staphylococcal colonization site (axillary folds, nostrils, navel, ears) and 1 point for the healthy skin area (cheek) if S. aureus is isolated after culture at M0, M6, and M12 in SPIDER+ patients.
Month 12
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients
Tidsramme: Month 0, baseline
Relative abundances (in %) of each bacterial species, including S. aureus following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
Month 0, baseline
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients: Alpha diversity
Tidsramme: Month 0, baseline
Calculation of alpha diversity (Shannon index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
Month 0, baseline
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients: Beta diversity
Tidsramme: Month 0, baseline
Calculation of beta diversity (Bray-Curtis index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
Month 0, baseline
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients
Tidsramme: Month 0, baseline
Relative abundances (in %) of each bacterial species, including S. aureus following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
Month 0, baseline
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients: Alpha diversity
Tidsramme: Month 0, baseline
Calculation of alpha diversity (Shannon index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
Month 0, baseline
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients: beta diversity
Tidsramme: Month 0, baseline
Calculation of beta diversity (Bray-Curtis index) following sequencing of swabs taken from a healthy skin area in SPIDER+ subjects and from a site at the same location in SPIDER- subjects at time point M0.
Month 0, baseline
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Tidsramme: Month 0, baseline
Measured in Mb
Month 0, baseline
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Tidsramme: Month 6
Measured in Mb
Month 6
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Tidsramme: Month 12
Measured in Mb
Month 12
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Tidsramme: Month 0, baseline
Measured in %
Month 0, baseline
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Tidsramme: Month 6
Measured in %
Month 6
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Tidsramme: Month 12
Measured in %
Month 12
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Tidsramme: Month 0, baseline
YES / NO
Month 0, baseline
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Tidsramme: Month 6
YES / NO
Month 6
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Tidsramme: Month 12
YES / NO
Month 12
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Tidsramme: Month 0, baseline
Measured in %
Month 0, baseline
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Tidsramme: Month 6
Measured in %
Month 6
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Tidsramme: Month 12
Measured in %
Month 12
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Tidsramme: Month 0, baseline
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 0, baseline
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Tidsramme: Month 6
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 6
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Tidsramme: Month 12
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 12
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Tidsramme: Month 0, baseline
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 0, baseline
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Tidsramme: Month 6
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 6
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Tidsramme: Month 12
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 12
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Tidsramme: Month 0, baseline
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 0, baseline
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Tidsramme: Month 6
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 6
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Tidsramme: Month 12
Measured via long-read sequencing (MinION, Oxford Nanopore) in µg
Month 12
Real-time monitoring of the growth of S. aureus strains isolated from SPIDER+ lesion sites
Tidsramme: Month 0 to Month 12
Real-time monitoring using the Quantum automat, in %
Month 0 to Month 12
Real-time monitoring of the growth of S. aureus strains isolated from apparently healthy areas in SPIDER+ patients
Tidsramme: Month 0 to Month 12
Real-time monitoring using the Quantum automat, in %
Month 0 to Month 12
Biofilm formation of S. aureus strains isolated from SPIDER+ lesion sites
Tidsramme: Month 0 to Month 12
Growth curves using the Bioflux automat
Month 0 to Month 12
Biofilm formation of S. aureus strains isolated from apparently healthy areas in SPIDER+ patients
Tidsramme: Month 0 to Month 12
Growth curves using the Bioflux automat
Month 0 to Month 12
Constitution of a biobank of samples taken by swabbing of lesion sites in SPIDER+ patients
Tidsramme: Month 0, baseline
Number of samples
Month 0, baseline

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Age of patients
Tidsramme: Month 0, baseline
The age of patients will be recorded in years
Month 0, baseline
Weight of patients
Tidsramme: Month 0, baseline
The weight of patients will be recorded in kilograms
Month 0, baseline
Height of patients
Tidsramme: Month 0, baseline
The height of patients will be recorded in centimeters
Month 0, baseline
Sex of patients
Tidsramme: Month 0, baseline
Male/Female/Non-binary
Month 0, baseline
Active smoker
Tidsramme: Month 0, baseline
YES/NO
Month 0, baseline
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score
Tidsramme: Month 0, baseline
The severity and duration of Inflammatory Bowel Disease will be recorded according to the Mayo Endoscopic Score. The Mayo Endoscopic Score is a 0 to 4 grading system (scored 0 to 3) used during a colonoscopy to assess the severity of inflammation in patients with ulcerative colitis based on the most involved area of the colon.
Month 0, baseline
The severity and duration of Inflammatory Bowel Disease according to the Harvey-Bradshaw Score
Tidsramme: Month 0, baseline

The severity and duration of Inflammatory Bowel Disease will be recorded according to the Harvey-Bradshaw Score. The Harvey-Bradshaw Index (HBI) is a simplified clinical questionnaire used to quantify the severity and monitor the progression of Crohn's disease. Developed in 1980, it serves as a streamlined alternative to the more complex Crohn's Disease Activity Index, relying primarily on symptoms from the previous day as follows:

General Well-Being:0: Very well1, Slightly below par 2, Poor 3, Very poor 4, Terrible Abdominal Pain:0, None1, Mild 2, Moderate 3, Severe Liquid Stools,1 point per bowel movement (Recorded for the previous day). Abdominal Mass:0, None1, Dubious 2, Definite 3, Definite and tender Complications (Score 1 point for each present condition). Joint pain (Arthralgia), Eye inflammation (Uveitis) Red, tender skin nodules (Erythema nodosum), Mouth ulcers (Aphthous ulcers), Necrotic skin ulcers (Pyoderma gangrenosum) Anal fissure, Fistula, Abscess.
Month 0, baseline
Montreal Inflammatory Bowel Disease Classification
Tidsramme: Month 0, baseline
The Montreal Inflammatory Bowel Disease Classification is the gold-standard for classifying Crohn's Disease and Ulcerative Colitis. Crohn's disease has 3 distinct variables (Age, Location, and Behavior):Age at Diagnosis (A):A1: ≤ 16 years, A2: 17 to 40 years, A3: > 40 years. Location (L):L1: Ileal (terminal ileum)L2: Colonic (large intestine)L3: Ileocolonic (both small and large intestine)L4: Upper Gastrointestinal tract (can coexist with L1-L3). Behavior (B):B1: Non-stricturing, non-penetrating (inflammatory phase)B2: Stricturing (narrowing of the bowel) B3: Penetrating (fistulae or abscesses)p: Perianal disease. Ulcerative Colitis is classified by the extent of anatomical involvement and severity:E1 (Ulcerative Proctitis): Limited strictly to the rectum.E2 (Left-sided UC): Extends up to the splenic flexure.E3 (Extensive/Pancolitis): Extends proximally past the splenic flexure, involving the whole colon.S0-S3 (Severity): Clinical remission (S0) to severe clinical attacks (S3).
Month 0, baseline
Treatments prior to initiation of anti-TNFα therapy, duration of anti-TNFα therapy and concomitant treatments.
Tidsramme: Month 0, baseline
All treatments prior to initiation of anti-TNFα therapy, the duration of anti-TNFα therapy and concomitant treatments will be recorded.
Month 0, baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Centre Hospitalier Universitaire de Nīmes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. september 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. september 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. september 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
26. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • AOI2024/2025/CDR-01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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