Fecal Microbiota Transplantation (FMT), Hidradenitis Suppurativa (HS)
Conditions
Brief 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. 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)
Interventions
DRUGFecal microbiota transplantation (FMT)
Fecal microbiota transplantation in patients with hidradenitis suppurativa
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) | 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 |
| At least a 50% improvement in lesions | 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 |
| Improvement of the HSPGA score (Hidradenitis Suppurativa Physician Global Assessment) | 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) |
| Pain improvement (Visual Analogue Scale) | At 12 and 24 weeks post-FMT | Pain improvement (VAS) at 12 and 24 weeks post-FMT |
| Improvement of flow (Visual Analogue Scale) | At 12 and 24 weeks post-FMT | Improvement of flow (VAS) at 12 and 24 weeks post-FMT |
| Improvement in quality of life (Dermatology Life Quality Index) | At 12 and 24 weeks post-FMT | Improvement in quality of life (DLQI) at 12 and 24 weeks post-FMT |
| Number and type of side effects | 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 |
| Analysis of patients' fecal microbiota | 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) |
| Analysis of the fecal microbiota of donors | 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) |
Countries
France
Contacts
CONTACTLise Laclautre
Outcome results
None listed