FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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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Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fecal microbiota transplantation (FMT)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov