Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Review and Track Patient reported Outcomes via Validated Questionnaires
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment.
The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18-75 years of age.
- •Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon
- •Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-
- •(The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response).
- •Patients may be on any class of IBD-related medication (excluding steroids)
- •Patients must be on stable medication regimen for at least 6 weeks prior to enrollment.
- •Ability to understand and willingness to sign informed consent document
排除标准
- •Patient who are asymptomatic
- •Patients with severe, refractory disease (defined as Mayo scores of > 10, or endoscopic disease activity score of > 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol
- •Prior colectomy
- •Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture.
- •Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
- •Systemic antibiotic use within prior 6 weeks to enrollment
- •Regular probiotic supplement use within prior 48 hours to enrollment
- •Pregnancy or breastfeeding
- •Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
- •History of anaphylaxis (severe allergic reaction)
- •Documented allergy to fluoroquinolones, metronidazole
- •Life expectancy less than 12 months
- •Age less than 18 or greater than 75 years of age
- •History of esophageal or gastric motility disorders.
研究组 & 干预措施
Treatment
FMT and microbial maintenance plus standard therapy
干预措施: Fecal Microbiota Transplant (Biological)
Control
Sham FMT and Sham Microbial Maintenance plus standard therapy
干预措施: Placebo (Biological)
结局指标
主要结局
Review and Track Patient reported Outcomes via Validated Questionnaires
时间窗: 2 Years
Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36)
Asses Endoscopic Stages of the Colon Pre/Post FMT
时间窗: 2 years
Assess endoscopic stage of the inflamed colon (endoscopic Mayo score) and assess the histologic stage of the biopsied colon (quiescent/mild/moderate/severe) pre and post FMT.
Asses Biologic Inflammatory Markers
时间窗: 2 years
Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.
次要结局
- Change in metagenomic sequencing in Stool samples after FMT treatment(After 6, 12, and 18 Weeks)
研究者
Peter L. Moses, MD
MD
University of Vermont