2024-517078-52-00招募中3 期
Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Delay between the date of transplantation and the date of the Clinical and endoscopic relapse defined by a Pouchitis Disease Activity Index (Appendix) ≥ 7 points.
研究概览
简要总结
To compare the relapse delay after fecal microbiota transplantation versus sham transplatation for recurrent pouchitis in IPAA for ulcerative colitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
- •Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure
- •Willing and able to adhere to the study visit scheduled and other protocol requirements
- •Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
- •Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).
- •Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
- •Subject must affiliation with social security system or beneficiary from such system
- •Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception
排除标准
- •Crohn disease or indeterminate colitis
- •Pregnant female or breastfeeding
- •Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures
- •Administration of investigational drug within 3 months prior to planned FMT
- •Adults under guardianship, Safeguard justice or trusteeship
- •Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
- •Patients with contraindication to colonoscopy or anesthesia (if necessary)
- •Anastomotic stenosis
- •Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
- •Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
- •Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit
- •Prior treatment with a biologic within 3 month prior the transplantation visit
- •Documented active infection of any kind in the last 6 months likely to require anti- infective treatment during the next months
- •Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
- •Infection with chronic HIV
结局指标
主要结局
Delay between the date of transplantation and the date of the Clinical and endoscopic relapse defined by a Pouchitis Disease Activity Index (Appendix) ≥ 7 points.
Delay between the date of transplantation and the date of the Clinical and endoscopic relapse defined by a Pouchitis Disease Activity Index (Appendix) ≥ 7 points.
次要结局
- Relapse at week 24 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 24
- Relapse at week 52 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 52
- Delay within the transplantation and the instauration of an antibiotherapy or alternative treatment (immunosuppressive and/or biotherapy and/or corticotherapy)
- Registered of adverse events defined by Common Terminology Criteria for Adverse Events (4.3) during 104 weeks post-transplantation according to ANSM recommendation.
- Fecal microbiota engraftment at 8 weeks defined by : Sorensen’s index [receiver 8 weeks after FMT vs donor] > Sorensen’s index [receiver 8 weeks after FMT vs receiver before FMT]) with Sorensen’s index [receiver 8 weeks after FMT vs donor] = 0.6. To assess this endpoint, fecal microbiota composition will be analyzed for donor sample, receiver sample before FMT and 8 weeks after FMT, using 16S sequencing (Illumina Miseq technology)
- IBD Disability Index at weeks -2, baseline, 8, 24, 52 and unscheduled visit
研究者
Soizic Boinet
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (14)
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