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Staph bacteria may hold clues to painful skin rashes in IBD patients on Anti-TNF therapy

NCT ID NCT07812675

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Some people with inflammatory bowel disease who take anti-TNF drugs develop painful rashes in skin folds and around the mouth, a condition called SPIDER. Researchers at a French hospital are studying whether levels of Staphylococcus aureus bacteria in these rashes change over six months and whether those changes match how the wounds heal. The study enrolls 82 people with IBD on anti-TNF therapy, some with SPIDER rashes and some without, and compares skin swabs from rashes, healthy skin, and clinical severity scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers link S. aureus levels to how these rashes heal, doctors could one day predict which patients improve and tailor skin care for people on anti-TNF therapy.
What could go wrong
This is a small observational study of 82 people at one hospital, so it can only show associations, not cause and effect. The findings may not apply to other IBD patients or other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 82 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Crohn disease dermatitis inflammatory bowel disease skin disorder staphylococcal infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Dermatitis Inflammatory bowel diseases Skin diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Béziers

    Béziers, Hérault, 34500, France

  • CHU de Montpellier, Hôpital Arnaud de Villeneuve

    Montpellier, Hérault, 34090, France

  • Centre Hospitalier de MILLAU

    Millau, Aveyron, 12100, France

  • Montpellier University Hospital, Saint Eloi

    Montpellier, Hérault, 34090, France

  • Nîmes University Hospital

    Nîmes, Gard, 30029, France

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