FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study (FESTIVAL)

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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Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa (HS); Fecal Microbiota Transplantation (FMT)
• Intervention / Treatment: Drug: Fecal microbiota transplantation (FMT)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 0473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux, Hôpital Saint-André
    • Principal Investigator: Marie BEYLOT-BARRY
  • Clermont-Ferrand, France
    • CHU Clermont Ferrand
    • Contact: lise Laclautre; Phone Number: +33473754131; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Jacques ROUANET
  • Clermont-Ferrand, France
    • CHU Clermont Ferrand, PIC/CIC
    • Principal Investigator: Gisèle PICKERING
  • Lyon, France
    • CHU Lyon
    • Principal Investigator: Axel VILLANI
  • Marseille, France
    • CHU Marseille, La Timone
    • Principal Investigator: Marie-Aleth RICHARD
  • Montpellier, France
    • CHU Montpellier
    • Principal Investigator: Céline GIRARD
  • Rodez, France
    • CH Rodez
    • Principal Investigator: Claire HOTZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with hidradenitis suppurativa receiving fecal microbiota transplantation	Drug: Fecal microbiota transplantation (FMT); Fecal microbiota transplantation in patients with hidradenitis suppurativa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System)	Improvement of at least 55% in the IHS4 score (which measures the number of nodules, abscesses, and fistulas with weighting according to the lesion) compared to baseline at the 24th week post-FMT	At the 24th week post-FMT
At least a 50% improvement in lesions	At least a 50% improvement in lesions (nodules and abscesses) without any new draining fistula or abscess (HiSCR50 score) at 12 and 24 weeks after FMT	At 12 and 24 weeks after FMT
Improvement of the HSPGA score (Hidradenitis Suppurativa Physician Global Assessment)	Improvement of the HSPGA score compared to baseline by 2 levels (for example, going from severe to mild)	At 12 and 24 weeks post-FMT
Pain improvement (Visual Analogue Scale)	Pain improvement (VAS) at 12 and 24 weeks post-FMT	At 12 and 24 weeks post-FMT
Improvement of flow (Visual Analogue Scale)	Improvement of flow (VAS) at 12 and 24 weeks post-FMT	At 12 and 24 weeks post-FMT
Improvement in quality of life (Dermatology Life Quality Index)	Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT	At 12 and 24 weeks post-FMT
Number and type of side effects	Number and type of side effects: any adverse event (of any grade according to the CTCAE) that could be related to the FMT should be reported, especially abdominal pain, bowel movement issues, and bacterial translocations from the day of the FMT up to 2 years after the FMT	From the day of the FMT up to 2 years after the FMT
Analysis of patients' fecal microbiota	Analysis of patients' fecal microbiota at inclusion and at the 12th week after FMT by sequencing the gene coding for the 16S small subunit ribosomal RNA (16S rRNA)	At inclusion and at the 12th week after FMT
Analysis of the fecal microbiota of donors	Analysis of the fecal microbiota of donors at their first stool donation by sequencing the gene coding for the bacterial ribosome's small subunit 16S RNA (16S rRNA)	At baseline

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: RBHP 2023 BUISSON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No