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Clinical Trials in France / NCT07668713
Starting soon Phase 1

FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

NCT07668713 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Clermont-Ferrand
Phase
Phase 1
Started
2026-06-01
Last updated
2026-06-25

Condition(s) studied

Hidradenitis Suppurativa (HS)Fecal Microbiota Transplantation (FMT)

Investigational drug(s) / intervention(s)

Fecal microbiota transplantation (FMT) →

Fecal microbiota transplantation (FMT): Fecal microbiota transplantation in patients with hidradenitis suppurativa

Study 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.

Translated with DeepL.com (free version)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) — At week 12 post FMT
    Improvement of at least 55% in the IHS4 score (a score assessing the number of nodules, abscesses, and fistulas with weighting according to the lesion) compared to baseline at the 12th week post-FMT (Day 104 ± 2 days).

Trial sites (7)

FacilityCityRegionStatus
CHU Bordeaux, Hôpital Saint-André Bordeaux France
CHU Clermont Ferrand, PIC/CIC Clermont-Ferrand France
CHU Clermont Ferrand Clermont-Ferrand France
CHU Lyon Lyon France
CHU Marseille, La Timone Marseille France
CHU Montpellier Montpellier France
CH Rodez Rodez France

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Other trials for the same condition

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib Recruiting
Neutralizing Interferon Type 1 in Hidradenitis Suppurativa Starting soon
Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms Starting soon
MAIT Cells in Hidradenitis Suppurativa Starting soon
A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07668713 on ClinicalTrials.gov ↗ ← All trials in France