Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

perjantai 4. syyskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Yksityiskohtainen kuvaus

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).

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Arvioitu)

82

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

  • Nimi: Anissa MEGZARI
  • Puhelinnumero: +334.66.68.42.36
  • Sähköposti: drc@chu-nimes.fr

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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)

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Relative abundance of S. aureus in the SPIDER+ group
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Aikaikkuna: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Aikaikkuna: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Aikaikkuna: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Aikaikkuna: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Aikaikkuna: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Aikaikkuna: Month 0, baseline
Yes/No
Month 0, baseline
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Aikaikkuna: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Aikaikkuna: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Aikaikkuna: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Aikaikkuna: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Aikaikkuna: Month 12
Yes/No
Month 12
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Aikaikkuna: Month 0, baseline
Yes/No
Month 0, baseline
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Aikaikkuna: Month 6
Yes/No
Month 6
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Aikaikkuna: Month 12
In %
Month 12
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Month 12
Measured in %
Month 12
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Month 0, baseline
Number of samples
Month 0, baseline

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Age of patients
Aikaikkuna: Month 0, baseline
The age of patients will be recorded in years
Month 0, baseline
Weight of patients
Aikaikkuna: Month 0, baseline
The weight of patients will be recorded in kilograms
Month 0, baseline
Height of patients
Aikaikkuna: Month 0, baseline
The height of patients will be recorded in centimeters
Month 0, baseline
Sex of patients
Aikaikkuna: Month 0, baseline
Male/Female/Non-binary
Month 0, baseline
Active smoker
Aikaikkuna: Month 0, baseline
YES/NO
Month 0, baseline
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Centre Hospitalier Universitaire de Nīmes

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Tiistai 1. syyskuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Perjantai 1. syyskuuta 2028

Opintojen valmistuminen (Arvioitu)

Lauantai 1. syyskuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 26. elokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 4. syyskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 10. syyskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 10. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 4. syyskuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • AOI2024/2025/CDR-01

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa