Hidradenitis Suppurativa (HS)Phase 1FESTIVALNCT07668713
FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study
A Phase 1 study testing Fecal microbiota transplantation (FMT) in people with Hidradenitis Suppurativa (HS) and Fecal Microbiota Transplantation (FMT), run by University Hospital, Clermont-Ferrand at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS), Fecal Microbiota Transplantation (FMT)
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Jun 2026to Jun 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
CHU Bordeaux, Hôpital Saint-André
Bordeaux
Marie BEYLOT-BARRY
CHU Clermont Ferrand, PIC/CIC
Clermont-Ferrand
Gisèle PICKERING
CHU Clermont Ferrand
Clermont-Ferrand
lise Laclautre, +33473754131, promo_interne_drci@chu-clermontferrand.fr
Jacques ROUANET
CHU Lyon
Lyon
Axel VILLANI
CHU Marseille, La Timone
Marseille
Marie-Aleth RICHARD
CHU Montpellier
Montpellier
Céline GIRARD
CH Rodez
Rodez
Claire HOTZ
About this study
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)
- Being tested
- Fecal microbiota transplantation (FMT)
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Drug
Fecal microbiota transplantation in patients with hidradenitis suppurativa
| Study group | Role | What they receive |
|---|---|---|
| Patients with hidradenitis suppurativa receiving fecal microbiota transplantation | Experimental | Not described Receives: Drug: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At week 12 post FMT
Secondary outcomes (9)
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
Measured: 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
Measured: 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)
Measured: At 12 and 24 weeks post-FMT
Pain improvement (Visual Analogue Scale)
Pain improvement (VAS) at 12 and 24 weeks post-FMT
Measured: At 12 and 24 weeks post-FMT
Improvement of flow (Visual Analogue Scale)
Improvement of flow (VAS) at 12 and 24 weeks post-FMT
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668713
- Sponsor's protocol ID
- RBHP 2023 BUISSON
- Acronym
- FESTIVAL
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No