FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

NCT07668713 | Not Yet Recruiting Phase 1

• 1 other identifier: RBHP 2023 BUISSON
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System)

  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).

  At week 12 post FMT

Secondary Outcomes (9)

• Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System)

  At the 24th week post-FMT

• At least a 50% improvement in lesions

  At 12 and 24 weeks after FMT

• Improvement of the HSPGA score (Hidradenitis Suppurativa Physician Global Assessment)

  At 12 and 24 weeks post-FMT

• Pain improvement (Visual Analogue Scale)

  At 12 and 24 weeks post-FMT

• Improvement of flow (Visual Analogue Scale)

  At 12 and 24 weeks post-FMT

Study Arms (1)

Patients with hidradenitis suppurativa receiving fecal microbiota transplantation

EXPERIMENTAL

Drug: Fecal microbiota transplantation (FMT)

Interventions

Fecal microbiota transplantation (FMT) DRUG

Fecal microbiota transplantation in patients with hidradenitis suppurativa

Patients with hidradenitis suppurativa receiving fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Allergy or contraindication to amoxicillin-clavulanic acid
• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (7)

CHU Bordeaux, Hôpital Saint-André

Bordeaux, France

Location

CHU Clermont Ferrand, PIC/CIC

Clermont-Ferrand, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CHU Lyon

Lyon, France

Location

CHU Marseille, La Timone

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CH Rodez

Rodez, France

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 25, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)