Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, Placebo-controlled, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The proportion of responders
研究概览
简要总结
The goal of this clinical trial is to determine efficacy of FMT via rectal enema and encapsulated FMT in patients with IBS in Thailand. The main question it aims to answer is:
• Does FMT provide better efficacy than placebo in IBS patients?
Participants will be randomized into 3 groups:
- In placebo group, patients will receive placebo capsules and placebo via enema.
- In enema group, patients will receive placebo capsules and FMT via rectal enema.
- In capsule group, patients will receive FMT capsules and placebo via rectal enema.
Researchers will compare FMT and placebo group to see if using FMT provides better efficacy for IBS patients than placebo. Moreover, researchers will compare efficacy of FMT capsules and FMT via rectal enema in IBS patients.
详细描述
Irritable bowel syndrome (IBS) is a common functional bowel disorder defined by recurrent abdominal pain related to defecation or a change in bowel habit (1). Pathogenic mechanisms of IBS include gut microbial dysbiosis, low-grade mucosal inflammation, increased gut permeability, and altered gut-brain interaction (2). Dysbiosis is an imbalance of gut microbiota which can contribute to IBS. Emerging treatment approach for IBS aims to correct dysbiosis by modulation of intestinal microbiota (3).
Fecal microbiota transplantation (FMT) is an administration of feces from a healthy donor to the gastrointestinal tract of a recipient in order to restore balanced microbial flora (4). Correcting gut dysbiosis might be another target to improve IBS symptoms. Some previous randomized controlled trials demonstrated that FMT could provide clinical response in patients with IBS (5-7), whereas others reported no different outcome from placebo (8, 9). Most trials delivered FMT via more invasive routes such as colonoscopy or gastroscopy. There were few studies using less invasive methods, e.g., oral FMT capsules and FMT via rectal enema. Less invasive routes of FMT administration are needed to be evaluated so as to reduce risk and cost of endoscopy.
This study aimed to determine efficacy of FMT via rectal enema and encapsulated FMT compared with placebo in IBS patients in Thailand.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years with IBS diagnosed by Rome IV criteria
- •Patients who can provide written informed consent.
排除标准
- •Pregnant or breastfeeding women
- •Severe comorbidities: chronic kidney disease (GFR<15 ml/min), cirrhosis, cancer, etc.
- •Fecal incontinence
- •Immunocompromised patients
- •Taking probiotic, or fermented food
- •Discontinue medication for IBS <1 month prior to study inclusion
研究组 & 干预措施
FMT rectal enema
Patients will receive FMT via rectal enema and placebo capsules.
干预措施: FMT via rectal enema (Drug)
FMT rectal enema
Patients will receive FMT via rectal enema and placebo capsules.
干预措施: Placebo capsules (Drug)
Encapsulated FMT
Patients will receive FMT capsules and placebo via rectal enema.
干预措施: FMT capsules (Drug)
Encapsulated FMT
Patients will receive FMT capsules and placebo via rectal enema.
干预措施: Placebo via rectal enema (Drug)
Placebo
Patients will receive placebo capsules and placebo via rectal enema.
干预措施: Placebo via rectal enema (Drug)
Placebo
Patients will receive placebo capsules and placebo via rectal enema.
干预措施: Placebo capsules (Drug)
结局指标
主要结局
The proportion of responders
时间窗: 4 weeks, 12 weeks
Response is defined as a decrease in IBS-symptom severity score (IBS-SSS) more than 50 points from baseline.
次要结局
- Adverse event(4 weeks, 12 weeks)
- Changes in microbiota diversity before and after FMT(4 weeks)
- Quality of life score(4 weeks, 12 weeks)
研究者
Natsuda Aumpan, MD
Principal Investigator
Thammasat University