FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

Обзор

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)

Вмешательства

• Препарат Fecal microbiota transplantation (FMT)
  Fecal microbiota transplantation in patients with hidradenitis suppurativa

Первичные конечные точки

• Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) [Срок оценки: At week 12 post FMT]

Вторичные конечные точки (9)

• Improvement of at least 55% in the IHS4 score (International Hidradenitis Suppurativa Severity Score System) [Срок оценки: At the 24th week post-FMT]
• At least a 50% improvement in lesions [Срок оценки: At 12 and 24 weeks after FMT]
• Improvement of the HSPGA score (Hidradenitis Suppurativa Physician Global Assessment) [Срок оценки: At 12 and 24 weeks post-FMT]
• Pain improvement (Visual Analogue Scale) [Срок оценки: At 12 and 24 weeks post-FMT]
• Improvement of flow (Visual Analogue Scale) [Срок оценки: At 12 and 24 weeks post-FMT]
• Improvement in quality of life (Dermatology Life Quality Index) [Срок оценки: At 12 and 24 weeks post-FMT]
• Number and type of side effects [Срок оценки: From the day of the FMT up to 2 years after the FMT]
• Analysis of patients' fecal microbiota [Срок оценки: At inclusion and at the 12th week after FMT]
• Analysis of the fecal microbiota of donors [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 7 центров

• CHU Bordeaux, Hôpital Saint-André — Bordeaux
• CHU Clermont Ferrand, PIC/CIC — Clermont-Ferrand
• CHU Clermont Ferrand — Clermont-Ferrand
• CHU Lyon — Lyon
• CHU Marseille, La Timone — Marseille
• CHU Montpellier — Montpellier
• CH Rodez — Rodez

Идентификаторы

NCT: NCT07668713 · RBHP 2023 BUISSON

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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