Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

Официальное название

Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study

Обзор

The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.

Подробное описание

This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.

Вмешательства

• Другое Fecal Microbiota transplant (FMT)
  Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years

Первичные конечные точки

• Efficacy of FMT donors at inducing UC remission [Срок оценки: 9 weeks]
• Efficacy of FMT at maintaining remission in UC [Срок оценки: 3 years]

Вторичные конечные точки (6)

• Efficacy of FMT at in inducing histological remission in active UC [Срок оценки: 9 weeks]
• Efficacy of FMT at relieving PRO2 symptoms [Срок оценки: 9 weeks]
• Efficacy of FMT at improving Quality of life [Срок оценки: 9 weeks and 3 years]
• Adverse effects of FMT [Срок оценки: 3 years]
• Stool microbiota predicting FMT success [Срок оценки: 9 weeks]
• Mucosal microbiota predicting FMT success [Срок оценки: 9 weeks]

Критерии участия

Критерии включения

• Patients aged 18 or over
• Active UC defined as a Mayo score (7) >3
• A Mayo endoscopic score (7) >0
• Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Критерии исключения

• Participating in another intervention study for UC
• Unable to give informed consent
• Severe comorbid medical illness
• Severe UC requiring hospitalization.
• Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
• Antibiotic therapy in the last 30 days.
• Pregnant women.
• Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range.
• Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L
• Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

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

Канада · 1 центр

• Hamilton Health Sciences / McMaster University — Hamilton

Публикации

• Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7. PMID 25857665

Идентификаторы

NCT: NCT04926103 · FUEL001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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