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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07812675). StuddyBuddy aggregates publicly available trial information.