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 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Stato
Non ancora reclutamento
Condizioni
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Tipo di studio
Osservativo
Iscrizione (Stimato)
Iscrizione
82
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Catherine DUNYACH-REMY, Dr.
- Numero di telefono: +334.66.68.32.02
- Email: catherine.remy@chu-nimes.fr
Backup dei contatti dello studio
- Nome: Anissa MEGZARI
- Numero di telefono: +334.66.68.42.36
- Email: drc@chu-nimes.fr
Luoghi di studio
-
-
Aveyron
-
Millau, Aveyron, Francia, 12100
- Centre Hospitalier de MILLAU
-
Contatto:
- Ariane FIZAZI, Dr.
- Email: a-fizazi@chu-montpellier.fr
-
Investigatore principale:
- Ariane FIZAZI, Dr.
-
-
Gard
-
Nîmes, Gard, Francia, 30029
- Nîmes University Hospital
-
Contatto:
- Catherine DUNYACH-REMY, Dr.
- Numero di telefono: +334.66.68.32.02
- Email: catherine.remy@chu-nimes.fr
-
Investigatore principale:
- Natacha CATTEAU, Dr.
-
Sub-investigatore:
- Blanche BERGERET, Dr.
-
Sub-investigatore:
- Ludovic CAILLO, Dr.
-
Sub-investigatore:
- Myriam MARQUE, Dr.
-
-
Hérault
-
Béziers, Hérault, Francia, 34500
- CHU de Béziers
-
Contatto:
- Louise GUILLON, Dr.
-
Investigatore principale:
- Louise GUILLON, Dr.
-
Sub-investigatore:
- Mohamed BEJAOUI, Dr.
-
Montpellier, Hérault, Francia, 34090
- CHU de Montpellier, Hôpital Arnaud de Villeneuve
-
Contatto:
- Grégoire LAVAUD, Dr.
- Email: gregoire.lavaud@chu-montpellier.fr
-
Investigatore principale:
- Grégoire LAVAUD, Dr.
-
Sub-investigatore:
- Yasmine JERIDI, Dr.
-
Sub-investigatore:
- Margot MIGNOT, Dr.
-
Sub-investigatore:
- Laura KOLLEN, Dr.
-
Montpellier, Hérault, Francia, 34090
- Montpellier University Hospital, Saint Eloi
-
Sub-investigatore:
- Romain ALTWEGG
-
Contatto:
- Aurélie DU THANH, Pr.
- Email: a-du_thanh@chu-montpellier.fr
-
Investigatore principale:
- Aurélie DU THANH
-
Sub-investigatore:
- Anne BOZON
-
Sub-investigatore:
- Lucile BOIVINEAU
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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)
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
2
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relative abundance of S. aureus in the SPIDER+ group
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Lasso di tempo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Lasso di tempo: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Lasso di tempo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Lasso di tempo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
Lasso di tempo: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Lasso di tempo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Lasso di tempo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Lasso di tempo: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Lasso di tempo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Lasso di tempo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Lasso di tempo: Month 12
|
Yes/No
|
Month 12
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Lasso di tempo: Month 0, baseline
|
Yes/No
|
Month 0, baseline
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Lasso di tempo: Month 6
|
Yes/No
|
Month 6
|
|
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Lasso di tempo: Month 12
|
In %
|
Month 12
|
|
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Month 12
|
Measured in %
|
Month 12
|
|
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Month 0, baseline
|
Number of samples
|
Month 0, baseline
|
Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Age of patients
Lasso di tempo: Month 0, baseline
|
The age of patients will be recorded in years
|
Month 0, baseline
|
|
Weight of patients
Lasso di tempo: Month 0, baseline
|
The weight of patients will be recorded in kilograms
|
Month 0, baseline
|
|
Height of patients
Lasso di tempo: Month 0, baseline
|
The height of patients will be recorded in centimeters
|
Month 0, baseline
|
|
Sex of patients
Lasso di tempo: Month 0, baseline
|
Male/Female/Non-binary
|
Month 0, baseline
|
|
Active smoker
Lasso di tempo: Month 0, baseline
|
YES/NO
|
Month 0, baseline
|
|
Severity and duration of Inflammatory Bowel Disease : Mayo Endoscopic Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
Inizio studio
1 settembre 2026
Completamento primario (Stimato)
Completamento primario
1 settembre 2028
Completamento dello studio (Stimato)
Completamento dello studio
1 settembre 2029
Date di iscrizione allo studio
Primo inviato
Primo inviato
26 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
4 settembre 2026
Primo Inserito (Effettivo)
Primo Inserito
10 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
10 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 settembre 2026
Ultimo verificato
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie intestinali
- Infezioni
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Gastroenterite
- Infezioni batteriche Gram-positive
- Infezioni batteriche
- Infezioni batteriche e micosi
- Malattie della pelle e del tessuto connettivo
- Infezioni da stafilococco
- Dermatite
- Malattia di Crohn
- Malattie infiammatorie intestinali
- Malattie della pelle
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- AOI2024/2025/CDR-01
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .