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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fecal microbiota transplantation (FMT)
DrugFecal microbiota transplantation in patients with hidradenitis suppurativa
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Patients with hidradenitis suppurativa receiving fecal microbiota transplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
At week 12 post FMTSecondary outcomes
1
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
Time frame
At the 24th week post-FMT2
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
Time frame
At 12 and 24 weeks after FMT3
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)
Time frame
At 12 and 24 weeks post-FMT4
Pain improvement (Visual Analogue Scale)
Pain improvement (VAS) at 12 and 24 weeks post-FMT
Time frame
At 12 and 24 weeks post-FMTSponsors and contacts
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Source ClinicalTrials.gov
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