Microbial Restoration in Inflammatory Bowel Diseases

Официальное название

The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases

Обзор

This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.

Подробное описание

The study will be conducted in two parts. The first part will involve all patients undergoing an optimisation phase, followed by randomisation into either intervention or placebo arms of the induction phase of the study. For patients achieving a pre-determined clinical response threshold at week 8 they will be re-randomised into the maintenance phase of the trial for a further 44 weeks.

FMT will be anaerobically prepared, freeze-thawed for administration.

Вмешательства

• Препарат Antibiotics
  All patients will receive a one week course of antibiotic therapy.
• Пищевая добавка Dietician designed diet
  All patients will be recommended dietary modification 3 weeks prior to, and during, the study.
• Препарат FMT
  Anaerobically prepared stool. Dosing will vary according to mode of administration.
• Другое Placebo
  Placebo will contain food colourant, 0.9% normal saline and glycerol.

Первичные конечные точки

• Clinical response [Срок оценки: Week 8]

Вторичные конечные точки (12)

• Clinical remission [Срок оценки: Week 8 and week 52 or Week 16 and week 60 (for open FMT group)]
• Endoscopic response [Срок оценки: Week 8 and 52 or Week 16 and 60]
• Endoscopic remission [Срок оценки: Week 8 and week 52 Week 16 and 60]
• Histological Remission [Срок оценки: Week 8 and 52 or Week 16 and 60]
• Radiological remission [Срок оценки: Week 8 and 52 or Week 16 and 60]
• Biochemical response [Срок оценки: Week 8 and 52 or Week 16 and 60]
• Time to outcomes [Срок оценки: Duration of trial]
• Maintenance of clinical remission [Срок оценки: Weeks 52 or 60]
• Sustained clinical remission [Срок оценки: Weeks 52 or 60]
• Steroid-free clinical remission [Срок оценки: Weeks 52 or 60]
• Safety outcomes [Срок оценки: Duration of trial]
• Scientific outcomes [Срок оценки: Week 8 and 52 or Week 16 and 60]

Критерии участия

Критерии включения

Active Crohn's disease

• Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND
• CDAI score of 220-450 AND
• One of the following:

• CRP ≥5mg/L
• faecal calprotectin ≥100μg/g
• inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)
• Willing and able to attend the study sites for regular endoscopic procedures.

Критерии исключения

Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose >20mg or budesonide dose >6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• St Vincents Hospital — Melbourne

Публикации

• Fehily SR, Wright EK, Basnayake C, Wilson-O'Brien AL, Stanley A, Marks EP, Russell EE, Hamilton AL, Bryant RV, Costello SP, Kamm MA. Faecal microbiota transplantation in Crohn's disease: an Australian randomised placebo-controlled trial protocol. BMJ Open. 2025 Apr 19;15(4):e094714. doi: 10.1136/bmjopen-2024-094714. PMID 40254304

Идентификаторы

NCT: NCT04970446 · StvincentsmelbourneMIROII

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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