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Not yet recruitingPhase 1

FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

Key facts

Phase
Phase 1

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Trial details

Who runs it
University Hospital, Clermont-Ferrand
Trial code
NCT07668713
Record updated
25 June 2026
Original description
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.Read full original descriptionShow less

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)

Inclusion: 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: Patient having received biomedication in the 3 months prior to inclusion; Concomitant Clostridioides Difficile infection; Allergy or contraindication to amoxicillin-clavulanic acid; Patient suffering from another inflammatory disease (IBD, inflammatory rheumatism, auto-inflammatory disease); HIV infection and active HBV/HCV hepatitis; Immunocompromised patients; 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.

ClinicalTrials.gov NCT07668713