A Randomised, Placebo-controlled Study on Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome With Fecal and Mucosal Microbiota Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- the proportion of responders
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections. The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.
详细描述
Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Until recently, the development of an effective therapy for this condition has been hampered by a poor understanding of the etiology of the disease. Traditionally the underlying pathogenesis of IBS has been centered on the brain-gut axis whereby stress and psychological conditions alter the perception of IBS symptoms. Emerging evidence however supports the observation that at least in a subgroup of patients with IBS, peripheral mechanisms within the intestine including low grade mucosal inflammation, abnormal immune activation and altered visceral sensitivity may be the main drivers of the manifestations in IBS.
Accumulating data suggest that the intestinal microbiota play an important role in the pathophysiology of IBS. This is derived from early observation that post-infectious IBS developed in a subgroup of patients following a bout of gastroenteritis. Several studies have shown that the fecal microbiota was altered in IBS and IBS symptoms can be improved by therapeutic interventions that target the microbiota including antibiotics, probiotics and prebiotics. Rifaximin, an oral, non-systemic broad spectrum antibiotics has also been shown to provide significant relief in IBS symptoms in a randomized controlled trial.
Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections.The mechanism of FMT in IBS is not completely clear.
The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are aged 18 or above
- •Patients have a diagnosis of IBS consistent with the Rome III criteria (13)
- •Patients did not have adequate relief of global IBS symptoms and of IBS-related bloating at both the time of screening and the time of randomization
- •Patients had undergone clinical investigations with colonoscopy within five years of recruitment
- •Patients with written informed consent form provided
排除标准
- •Patients have constipation predominant IBS (according to the definition of Rome III criteria)
- •Patients have a history of inflammatory bowel disease or gastrointestinal malignancy
- •Patients have previous abdominal surgery (other than cholecystectomy or appendectomy)
- •Patients have human immunodeficiency virus infection
- •Patients have renal disease manifested by 1.5 times the ULN of serum creatinine or blood urea nitrogen level
- •Patients have hepatic disease manifested by twice the upper limit of normal (ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin
- •Patients have diabetes mellitus manifested by HbA1C > 6.5%
- •Patients have abnormal thyroid function manifested by values of serum Sensitive Thyroid Stimulating Hormone and serum free T4 fall outside the reference range which is not controlled by thyroid medications
- •Patients have a history of psychiatric illness (mania and schizophrenia)
- •Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9) score > 15
- •Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7) score > 10
- •Patients have active infection at the time of inclusion
- •Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days
- •Patients have any other organic causes that can explain the symptoms of IBS
- •Current pregnancy
结局指标
主要结局
the proportion of responders
时间窗: 12 weeks
Response means a symptom relief of more than 50 points assessed by IBS-SSS.
次要结局
- Assess the change of abdominal pain scores in patients who undergo open-label FMT(12 weeks)
- The proportion of patients who had improvement on abdominal bloating(12 weeks)
- Assess the Stool consistency between two groups(12 weeks)
- Health-related quality of life in patients with irritable bowel syndrome(12 weeks)
- Assess the onset and duration of relief of general IBS symptoms(12 weeks)
- Assess the onset and duration of abdominal bloating relief(12 weeks)
- Assess the Abdominal pain between two groups(12 weeks)
- Assess the level of anxiety between two groups(12 weeks)
- The proportion of patients who undergo open-label FMT and have abdominal bloating relief(12 weeks)
- The IBS quality of life change in patients who undergo open-label FMT(12 weeks)
- The changes in gut microbiota at species and functional levels(12 weeks)
- The similarity of gut microbiota to donors(12 weeks)
- The proportion of patients who had adequate relief of general IBS symptoms(12 weeks)
- The level of anxiety change in patients who undergo open-label FMT(12 weeks)
- The changes in diversity and richness of gut microbiota(12 weeks)
研究者
Siew Chien NG
Professor
Chinese University of Hong Kong