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

NCT07812675 | Not Yet Recruiting

• 1 other identifier: AOI2024/2025/CDR-01
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Inflammatory Bowel Diseases; Crohn's Disease; Skin Diseases; Dermatitis

Keywords

anti-TNFα therapies; Inflammatory Bowel Diseases; Staphylococcus aureus

Outcome Measures

Primary Outcomes (7)

• Relative abundance of S. aureus in the SPIDER+ group

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (73)

• Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment 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

  Month 12

• Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index

  Month 0, baseline

• Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index

  Month 12

• Relative abundance of species found in the experimental group (SPIDER+ patients)

  Month 0, baseline

Other Outcomes (9)

• Age of patients

  Month 0, baseline

• Weight of patients

  Month 0, baseline

• Height of patients

  Month 0, baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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

You may not qualify if:

• 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 under legal guardianship, conservatorship, or trusteeship
• Patients who refuse to sign the informed consent form
• Pregnant or breastfeeding patients.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (5)

Centre Hospitalier de MILLAU

Millau, Aveyron, 12100, France

Location

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

CHU de Béziers

Béziers, Hérault, 34500, France

Location

CHU de Montpellier, Hôpital Arnaud de Villeneuve

Montpellier, Hérault, 34090, France

Location

Montpellier University Hospital, Saint Eloi

Montpellier, Hérault, 34090, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Swabs from SPIDER-affected and healthy skin areas frozen to -80°C. Once thawed, DNA will be extracted. Targeted metagenomic analysis via 16S rRNA gene sequencing (Illumina protocol for V3-V4 hypervariable regions). Final libraries will be diluted to 9 nM and pooled with 25% PhiX control to enhance sequencing diversity (single run sequencing in paired-end 2×300 bp mode on Illumina MiSeq platform). Quality filtering, chimera removal, error correction, taxonomic classification for raw sequences via DADA2 pipeline in R (v.1.34.0). Bacteria will be cultured on Chapman medium, Staphylococcus sp. selected from swabs taken from lesions and reservoirs. Illumina® sequencing of S. aureus strains isolated from lesions, healthy areas, and reservoirs. Real-time PCR to assess transcription levels of S. aureus genes under study. Growth curves will be generated via Quantum®. Biofilm assays will made via Bioflux®

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Skin Diseases; Dermatitis; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Skin and Connective Tissue Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Catherine DUNYACH-REMY, Dr.

CONTACT

+334.66.68.32.02; catherine.remy@chu-nimes.fr

Anissa MEGZARI

CONTACT

+334.66.68.42.36; drc@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 10, 2026

Record last verified: 2026-08

Locations

FR (5)