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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hidradenitis suppurativa receiving fecal microbiota transplantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation (FMT) | Drug | Fecal microbiota transplantation in patients with hidradenitis suppurativa |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At week 12 post FMT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At the 24th week post-FMT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 0473754963 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux, Hôpital Saint-André | Bordeaux | France |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 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 |
| 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) | At 12 and 24 weeks post-FMT |
| Pain improvement (Visual Analogue Scale) | Pain improvement (VAS) at 12 and 24 weeks post-FMT | At 12 and 24 weeks post-FMT |
| Improvement of flow (Visual Analogue Scale) | Improvement of flow (VAS) at 12 and 24 weeks post-FMT | 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 | 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 | 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) | 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) | At baseline |
| CHU Clermont Ferrand, PIC/CIC | Clermont-Ferrand | France |
|
| CHU Clermont Ferrand | Clermont-Ferrand | France |
|
| CHU Lyon | Lyon | France |
|
| CHU Marseille, La Timone | Marseille | France |
|
| CHU Montpellier | Montpellier | France |
|
| CH Rodez | Rodez | France |
|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |