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NCT07812675
Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER).
Conditions: Inflammatory Bowel Diseases, Crohn's Disease, Skin Diseases, Dermatitis
Sex: All
Ages: 4 Years – N/A
Healthy volunteers: No
Enrollment: 82
Sponsor: Centre Hospitalier Universitaire de Nīmes
Location: Centre Hospitalier de MILLAU Millau Aveyron
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07812675). StuddyBuddy aggregates publicly available trial information.