Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating: a Double Blind, Placebo Controlled Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Reduction of overall IBS symptoms (Key question 1)
研究概览
简要总结
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.
In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.
In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT.
详细描述
Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.
In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.
In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT. Donors for this study will be recruited from a healthy donor pool who will donate stool after clearance of a strict inclusion protocol which will assess the presence of any infectious diseases. Stool will be frozen following the protocol described in Hamilton et al 2012. Patients will deliver a stool portion that will be frozen as well.
At time of FMT, patients will be randomised in a double blinded fashion to the treatment arm (healthy donor stool) or placebo arm (own stool). Transplantation will be preformed by means of a colonoscopy with deliverance in the right colon and ileum.
Following FMT patients will be followed clinically with questionnaires and regular visits to the clinic. Stool samples will be collected on a regular basis for microbiome analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Inclusion Criteria for patients:
- •signed informed consent
- •Irritable bowel syndrome with predominant diarrhoea as defined by the ROME III criteria and with symptoms of abdominal bloating
- •IBS symptom score > 3 on at least 2 subscores (abdominal discomfort, abdominal bloating, abdominal pain, urgency, stool frequency, stool consistency)
排除标准
- •for patients:
- •predominant constipation as defined by Rome III criteria
- •pregnancy or inadequate anti conception for the duration of the trial
- •celiac disease
- •any contra-indications for colonoscopy
- •structural abnormalities of the colon (e.g. ileocecal resection, gastric bypass)
- •severe gastro-intestinal comorbidities (e.g. IBD, coloncarcinoma)
- •non gastro-intestinal malignancy
- •severe psychiatric comorbidity which had important effects on the quality of life
- •antimicrobial treatment 4 weeks prior to screening visit
- •treatment with probiotics 2 weeks prior to screening visit
- •recent diagnosis of lactose intolerance (< 3 months before screening visit)
- •any severe comorbidity that might interfere with the study course as determined by the treating physician
- •Inclusion criteria for donors
- •age 18 - 75 years
- •signed informed consent
- •normal screening protocol which includes screening for infectious diseases (eg. blood HIV, Syphilis, Hepatitis B or C; stool: enteropathogens, clostridium, ESBL, CPE)
- •Exclusion criteria for donors
- •presence of gastrointestinal symptoms
- •gastro-intestinal or other important comorbidity
- •obesity or metabolic syndrome
- •history of malignancy both gastrointestinal or systemic
- •presence of known colon polyps
- •recent placing of piercings/tattoos
- •sexual risk behaviour
- •antimicrobial therapy 3 months prior to donation
研究组 & 干预措施
Placebo group (FMT with own stool)
Fecal microbiota transplantation with patient's own stool
干预措施: FMT with own stool (Procedure)
Treatment group (FMT with donor stool)
Fecal microbiota transplantation with healthy donor stool
干预措施: FMT with donor stool (Procedure)
结局指标
主要结局
Reduction of overall IBS symptoms (Key question 1)
时间窗: 3 months after FMT
On a weekly basis patients will assess their overall IBS symptoms by answering a key question (Are your overall symptoms improved as compared to before the treatment?)
Reduction of abdominal bloating (Key question 2)
时间窗: 3 months after FMT
On a weekly basis patients will assess their sensation of abdominal bloating by answering a key question (Is your overall sensation of bloating improved by FMT as compared to before treatment?)
次要结局
- Changes in IBS symptom scores at three months after FMT(3 months after FMT)
- Changes in IBS symptom scores at six months post FMT(6 months)
- Composition of mucosal-adherent microbiota (Illumina sequencing)(3 months)
- Changes in IBS symtom scores at 9 months post FMT(9 months)
- Changes of IBS symptom scores in patients who undergo an off-trial FMT(3 months)
- Changes in fecal microbiome composition (Illumina sequencing)(3 months after FMT)
- Changes in IBS symptom scores at 1 year post FMT(1 year)
研究者
Gastro-enterologie
Gastro-enterologie
University Hospital, Ghent