FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study (NCT07668713) | Clinical Trial Compass
Not Yet RecruitingPhase 1
FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study
France24 participantsStarted 2026-06-01
Plain-language summary
The medical and surgical treatment of hidradenitis suppurativa (HS) remains difficult to date. The search for new therapies for HS is a major challenge. The pathophysiology of HS, the similarities with Crohn's disease and the data in the literature suggest a role for the digestive flora in HS. The role of the intestinal microbiota has now been clearly demonstrated in the pathophysiology of chronic inflammatory bowel disease (IBD), and is suspected in many other diseases. Fecal microbiota transplantation (FMT) is the gold-standard treatment for recurrent Clostridioides Difficile infection, and is being investigated in a wide range of conditions. Our hypothesis is that FMT would improve inflammatory lesions of HS by modifying patients' digestive microbiota.
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Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Patient with Hurley HS II (moderate severity) or III (very severe)
* Axillomammary (LC1) or gluteal (LC3) phenotype with at least 4 inflammatory lesions: inflammatory nodule, abscess or active fistula
* Having presented at least one relapse to a well-conducted medical treatment as proposed by the 2019 French Dermatology Society evidence center recommendations (broad-spectrum antibiotic therapy for 15 to 21 days followed by prophylactic treatment with doxycycline or cotrimoxazole). A relapse is defined as the occurrence of a new attack within 3 months of the introduction of treatment.
Exclusion Criteria:
* Allergy or contraindication to amoxicillin-clavulanic acid
* Patient having received biomedication in the 3 months prior to inclusion
* Patient suffering from another inflammatory disease (IBD, inflammatory rheumatism, auto-inflammatory disease)
* Concomitant Clostridioides Difficile infection
* Immunocompromised patients
* HIV infection and active HBV/HCV hepatitis
* No health insurance
* Pregnant or breast-feeding women
* Patients already included in a biomedical research study other than an observational study (e.g. registry, cohort)
* Patients under guardianship/curatorship/legal protection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System)