ALLOGENEIC FAECAL MICROBIOTA for Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years old"}
• {"criterion_text":"- Presenting HS Hurley II (moderate severity) or III (very severe) and an “axillo-mammary” (LC1) or “gluteal” (LC3) phenotype with at least 4 inflammatory lesions: inflammatory nodule, abscess or active fistula"}
• {"criterion_text":"- Having presented at least one relapse to well-conducted medical treatment as proposed by the recommendations of the SFD evidence center, i.e. broad-spectrum antibiotic therapy for 15 to 21 days then prophylactic treatment with doxycycline or cotrimoxazole. A relapse is defined by the occurrence of a new attack within 3 months following the introduction of treatments."}
• {"criterion_text":"- Speaking and understanding French"}

Exclusion criteria

• {"criterion_text":"- Allergy or contraindication to amoxicillin-clavulanic acid"}
• {"criterion_text":"- Patient having received treatment with biomedicines in the 3 months preceding inclusion"}
• {"criterion_text":"- Patient suffering from another inflammatory disease (IBD, inflammatory rheumatism, auto-inflammatory disease)"}
• {"criterion_text":"- Concomitant Clostridioides Difficile infection"}
• {"criterion_text":"- Immunocompromised patient"}
• {"criterion_text":"- Infection with HIV or viral hepatitis HBV HCV"}
• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Patient under guardianship/curatorship/under legal protection"}

Primary endpoints

• {"endpoint_text":"- Improvement of at least 55% in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to the baseline state at the 12th week post FMT (D104 +- 2 days)","definition_or_measurement_approach":"Measured as at least 55% improvement in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to baseline at week 12 post-FMT (D104 ± 2 days)."}

Secondary endpoints

• {"endpoint_text":"- Improvement of at least 55% in the IHS4 score (score evaluating the number of nodules, abscesses and fistulas with weighting according to the lesion) compared to the baseline state at the 24th week post FMT","definition_or_measurement_approach":"Measured as at least 55% improvement in the IHS4 score compared to baseline at week 24 post-FMT."}
• {"endpoint_text":"- Improvement of at least 50% of lesions (nodules and abscesses) without new draining fistula or abscess (HiSCR50 score) at 12 and 24 weeks post-FMT","definition_or_measurement_approach":"Measured by HiSCR50: ≥50% reduction in nodules and abscesses with no new draining fistula or abscess at weeks 12 and 24 post-FMT."}
• {"endpoint_text":"- Improvement of the HSPGA score compared to the base state by 2 ranks (for example change from severe to mild score)","definition_or_measurement_approach":"Measured as a 2-rank improvement in HSPGA score compared to baseline (e.g., severe to mild)."}
• {"endpoint_text":"- Improvement in pain (VAS) at 12 and 24 weeks post-FMT","definition_or_measurement_approach":"Measured by pain Visual Analog Scale (VAS) at weeks 12 and 24 post-FMT."}
• {"endpoint_text":"- Improved flow (VAS) at 12 and 24 weeks post-FMT","definition_or_measurement_approach":"Measured by flow (likely discharge) Visual Analog Scale (VAS) at weeks 12 and 24 post-FMT."}
• {"endpoint_text":"- Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT","definition_or_measurement_approach":"Measured by Dermatology Life Quality Index (DLQI) at weeks 12 and 24 post-FMT."}
• {"endpoint_text":"- Number and type of side effects: any adverse event (of any grade according to the CTCAE) that may be linked to FMT must be reported, in particular abdominal pain, transit disorders and bacterial translocations from the day of FMT until 6 months post FMT","definition_or_measurement_approach":"All adverse events of any grade (per CTCAE) potentially linked to FMT to be reported from day of FMT until 6 months post-FMT, with particular attention to abdominal pain, transit disorders and bacterial translocations."}
• {"endpoint_text":"- Analysis of the fecal microbiota of patients at inclusion and at the 12th week post FMT by sequencing the gene encoding the RNA of the small 16S subunit of the bacterial ribosome (16S RNA)","definition_or_measurement_approach":"Microbiota analysis by 16S rRNA gene sequencing on patient stool samples at inclusion and week 12 post-FMT."}
• {"endpoint_text":"- Analysis of the fecal microbiota of donors at the first stool donation by sequencing the gene coding for the RNA of the small 16S subunit of the bacterial ribosome (16S RNA)","definition_or_measurement_approach":"Microbiota analysis by 16S rRNA gene sequencing on donor stool at first donation."}

Methods

• Recruitment arrangements document present (K1_RECRUITMENT ARRANGEMENTS) — country: France
• Recruitment announcements for patients (document: Annonce de recrutement_Patient_Festival) — target audience: patients with hidradenitis suppurativa, country: France
• Recruitment announcements for donors (document: Annonce de recrutement_Donneurs_Festival) — target audience: stool donors, country: France
• Use of subject information and informed consent forms for patients and donors (documents: L1_SIS and ICF Patients; L1_SIS and ICF Donneurs)

France

Earliest CTIS Part Ii Submission Date

17-06-2025

Latest Decision Or Authorization Date

24-06-2025

Processing Time Days

7

Number Of Sites

7

Number Of Participants

24

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France