Menu
Not yet recruiting NCT07668713

FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

Phase I Interventional Hidradenitis Suppurativa (HS) Fecal Microbiota Transplantation (FMT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbiota transplantation (FMT).
Who it may be relevant to
Registry conditions: Hidradenitis Suppurativa (HS), Fecal Microbiota Transplantation (FMT). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

  • Drug Fecal microbiota transplantation (FMT)
    Fecal microbiota transplantation in patients with hidradenitis suppurativa

Primary outcome measures

  • Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) [Time frame: At week 12 post FMT]
Secondary outcome measures (9)
  • Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) [Time frame: At the 24th week post-FMT]
  • At least a 50% improvement in lesions [Time frame: At 12 and 24 weeks after FMT]
  • Improvement of the HSPGA score (Hidradenitis Suppurativa Physician Global Assessment) [Time frame: At 12 and 24 weeks post-FMT]
  • Pain improvement (Visual Analogue Scale) [Time frame: At 12 and 24 weeks post-FMT]
  • Improvement of flow (Visual Analogue Scale) [Time frame: At 12 and 24 weeks post-FMT]
  • Improvement in quality of life (Dermatology Life Quality Index) [Time frame: At 12 and 24 weeks post-FMT]
  • Number and type of side effects [Time frame: From the day of the FMT up to 2 years after the FMT]
  • Analysis of patients' fecal microbiota [Time frame: At inclusion and at the 12th week after FMT]
  • Analysis of the fecal microbiota of donors [Time frame: At baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 7 centers
  • CHU Bordeaux, Hôpital Saint-André — Bordeaux
  • CHU Clermont Ferrand, PIC/CIC — Clermont-Ferrand
  • CHU Clermont Ferrand — Clermont-Ferrand
  • CHU Lyon — Lyon
  • CHU Marseille, La Timone — Marseille
  • CHU Montpellier — Montpellier
  • CH Rodez — Rodez

Identifiers

NCT: NCT07668713 · RBHP 2023 BUISSON

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗