A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Clinical Response
研究概览
简要总结
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.
详细描述
This is a randomized, double-blind, placebo-controlled clinical trial with the following treatment assignments:
-
Investigational FMT (one-time)
-
Subject will blindly receive investigational FMT once at day 0 colonoscopy
-
Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
-
Investigational FMT (one-time) + Psyllium (2x/day for 8 weeks)
-
Subject will blindly receive investigational FMT once at day 0 colonoscopy
-
Subjects in this group will blindly receive placebo FMP250 at week 8 by flexible sigmoidoscopy.
-
Placebo FMT (one-time) +/- Psyllium (2x/day for 8 weeks)
-
Subject will blindly receive placebo FMT once at day 0 colonoscopy
-
Subjects in this group will blindly receive investigational FMP250 at week 8 by flexible sigmoidoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blinded study
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥ 18 years of age.
- •Documentation of prior history of mild to moderate UC.
- •Endoscopy confirmed active UC ≥ 15 centimeters at week 0 screening colonoscopy.
- •a. As defined by a total Mayo scoring of 4-10 with an endoscopic sub-score ≥
- •Patients must have a descending intact colon.
- •Patients taking steroid or biologic therapy must be on a stable dose for 4 weeks prior to screening and maintained throughout the trial.
- •Eligible patients willing to undergo screening testing prior to FMT to document baseline status:
- •Urine Testing
- •Blood Testing
- •Stool Testing
- •Patients must discontinue anti-rCDI antibiotics (e.g. vancomycin, fidaxomicin) 48 hours prior to FMT delivery procedure.
排除标准
- •Biopsy proven Crohn's disease
- •UC patients with severe disease (defined as a total mayo score >10)
- •Clinical complications requiring emergent management (e.g. stricture, bowel obstruction, perforation and/or abscess)
- •Concurrent C. difficile or other infections
- •Primary sclerosing cholangitis
- •Prior history of FMT
- •Treatment for malignancy within past 5 years
- •Active or latent tuberculosis
- •Clinically meaningful laboratory abnormalities
- •ALT: greater than 3x the ULN (upper limit of normal)
- •History of anaphylactic reactions to food allergens or allergy to psyllium husk
- •Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the study.
研究组 & 干预措施
Investigational FMT
Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy.
Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy.
干预措施: Fecal Microbiota Transplantation (Drug)
Investigational FMT + psyllium fiber
Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks.
Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy.
干预措施: Fecal Microbiota Transplantation (Drug)
Investigational FMT + psyllium fiber
Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks.
Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy.
干预措施: Psyllium Husk Powder (Dietary Supplement)
Placebo FMT +/- psyllium fiber
Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks.
Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy.
干预措施: Psyllium Husk Powder (Dietary Supplement)
结局指标
主要结局
Clinical Response
时间窗: Week 8 post-FMT
Clinical response at week 8 post-FMT, as defined by the reduction of the Mayo scoring system by \>3 points (+30% reduction) with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point
次要结局
- Clinical Remission(Week 8 post-FMT)
- Endoscopic Response or Remission(Week 8 post-FMT)
- Number of Treatment or Disease Related Adverse Events.(Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT)