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NCT Number: NCT07668713

FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot 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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Fecal Microbiota Transplantation (FMT) Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Bordeaux, Hôpital Saint-André, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal microbiota transplantation (FMT)

Drug

Fecal microbiota transplantation in patients with hidradenitis suppurativa

Primary outcomes

  1. Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System)

    Time frame: At week 12 post FMT

    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).

Secondary outcomes

  1. Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System)

    Time frame: At the 24th week post-FMT

    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

  2. At least a 50% improvement in lesions

    Time frame: At 12 and 24 weeks after FMT

    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

  3. Improvement of the HSPGA score (Hidradenitis Suppurativa Physician Global Assessment)

    Time frame: At 12 and 24 weeks post-FMT

    Improvement of the HSPGA score compared to baseline by 2 levels (for example, going from severe to mild)

  4. Pain improvement (Visual Analogue Scale)

    Time frame: At 12 and 24 weeks post-FMT

    Pain improvement (VAS) at 12 and 24 weeks post-FMT

  5. Improvement of flow (Visual Analogue Scale)

    Time frame: At 12 and 24 weeks post-FMT

    Improvement of flow (VAS) at 12 and 24 weeks post-FMT

  6. Improvement in quality of life (Dermatology Life Quality Index)

    Time frame: At 12 and 24 weeks post-FMT

    Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT

  7. Number and type of side effects

    Time frame: From the day of the FMT up to 2 years after the FMT

    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

  8. Analysis of patients' fecal microbiota

    Time frame: At inclusion and at the 12th week after FMT

    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)

  9. Analysis of the fecal microbiota of donors

    Time frame: At baseline

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

0473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: FESTIVAL

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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