FESTIVAL_Fecal transplantation in Hidradenitis suppurativa : a pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-06-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Therapy

Evaluate the effectiveness of the amoxicillin-clavulanic acid antibiotic strategy followed by FMT on disease activity at the 12th week (IHS4-55) post FMT in patients with recurrent moderate to severe HS after treatment conducted according to French recommendations.

Secondary objectives 9

1. Evaluate the effectiveness of the antibiotic strategy amoxicillin-clavulanic acid then FMT in the medium term on disease activity (IHS4-55) at the 24th week post-FMT
2. Evaluate the effectiveness of the antibiotic strategy amoxicillin-clavulanic acid then FMT in the medium term on disease activity (IHS4-55) at the 24th week post-FMT
3. Evaluate the effectiveness of the amoxicillin-clavulanate antibiotic strategy followed by short- and medium-term FMT on disease activity (HSPGA) at 12 and 24 weeks post-FMT
4. Evaluate the impact of the amoxicillin-clavulanic acid antibiotic strategy then FMT on pain (pain VAS) at 12 and 24 weeks post-FMT
5. Evaluate the impact of the antibiotic strategy amoxicillin-clavulanic acid then FMT on flow (VAS flow) at 12 and 24 weeks post-FMT
6. Evaluate the quality of life (DLQI) of patients at the 12th and 24th week post FMT as well as its evolution compared to the initial state
7. Evaluate the tolerance of FMT
8. Evaluate the changes in the fecal microbiota of patients at the 12th week post FMT compared to inclusion
9. Identify microbial factors in the fecal microbiota of donors which would have a positive impact on the outcome of patients or on the contrary negative, in order to define criteria for choosing an optimal stool donor in the context of this pathology

Conditions and MedDRA coding

Hidrdenitis suppurative

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients ≥ 18 years old
2. 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
3. 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.
4. Speaking and understanding French

Exclusion criteria 8

1. Allergy or contraindication to amoxicillin-clavulanic acid
2. Patient having received treatment with biomedicines in the 3 months preceding inclusion
3. Patient suffering from another inflammatory disease (IBD, inflammatory rheumatism, auto-inflammatory disease)
4. Concomitant Clostridioides Difficile infection
5. Immunocompromised patient
6. Infection with HIV or viral hepatitis HBV HCV
7. Pregnant or breastfeeding women
8. Patient under guardianship/curatorship/under legal protection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 9

1. 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
2. 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
3. Improvement of the HSPGA score compared to the base state by 2 ranks (for example change from severe to mild score)
4. Improvement in pain (VAS) at 12 and 24 weeks post-FMT
5. Improved flow (VAS) at 12 and 24 weeks post-FMT
6. Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT
7. 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
8. 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)
9. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont-Ferrand

Postcode

63000

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

lise Laclautre

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications