Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The effect of FMT for tolerance of FODMAPs in the IBS patients' diet
研究概览
简要总结
Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.
The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.
详细描述
This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Coputer based randomization
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
- •Adults, age 18-75 years, knowledge of the Finnish language
- •IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
- •The patient must consume low FODMAP diet to control IBS symptoms
- •Patient must sign the informed consent
排除标准
- •Diagnosed allergies to food components in the study dietary protocol
- •Pregnancy and breastfeeding
- •Antibiotic treatment less than three months prior enrolment
- •Faecal incontinence, i.e., inability to retain enema
- •Abuse of drugs, alcohol or medications
- •Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
- •Severe psychiatric or neurologic condition decreasing patient's compliance
结局指标
主要结局
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet
时间窗: FMT and IBS
With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.
次要结局
- Microbial components explaining the successful broadening of FODMAP diet in IBS patients.(Microbiome and FODMAP)
- GI symptoms and bacterial fermentaiton status in IBS(Bacterial fermentation status and IBS)
研究者
Perttu Arkkila
Professor
Helsinki University Central Hospital