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ClinicalTrials.gov ID

NCT07668713

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

24Estimated

Last Update Posted

Jun 25, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Jun 2030Estimated

Completion Date

Jun 2031Estimated

Official Title

FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

Brief 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)

• Hidradenitis Suppurativa (HS)
• Fecal Microbiota Transplantation (FMT)

• Fecal microbiota transplantation (FMT)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

promo_interne_drci@chu-clermontferrand.fr+33473754131