Characterisations of Microbial Community Composition and Kinetics Following Faecal Microbiota Transplantation in Patients WITH IRRITABLE BOWEL SYNDROME
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Stool microbiota changes
研究概览
简要总结
The study will characterize the biology of FMT in the context of IBS prior to wider clinical application of the method. Given the ethical concerns of unknown and long-term adverse effects of FMT therapy, the study will include patients only with moderate to severe symptoms. IBS is a heterogenous disorder and it is important to characterize the patients, and study as homogeneous patient populations as possible. Therefore the study will only include post-infectious IBS patients after the Giardia outbreak.
详细描述
Primary aims:
Detailed characterisation of donor and recipient microbial community composition (by means of 16S rRNA profiling) and determination of the kinetics of changes following FMT
Secondary aims:
- Determination of interactions of importance to persisting recipient gut microbiota.
- Evaluate safety of FMT in an IBS population
- To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in an open pilot trial in order to have the possibility to calculate number of patients needed when planning future controlled studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Age between 18-and 70 years
- •IBS-SSS (IBS-Symptom Severity Scale) score >175 (175 - 300 represents moderate, > 300 represent severe IBS).
- •All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or alternating constipation and diarrhoea (IBS-A) with bloating or flatulence as predominant symptoms. Only IBS considered post-infectious after the Bergen Giardia outbreak will be included. The severity of global IBS symptoms has to be either moderate ("cannot be ignored but do not influence daily activities") or severe ("influence daily activities"). A decrease of 50 points on the IBS-SSS has been shown to correlate with improvement in clinical symptoms. All patients will undergo appropriate investigations to exclude organic disease.
排除标准
- •History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool or antibiotic use within 1 month prior to FMT, immunocompromised patient defined as taking immuno-suppressive medications, history of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
- •Patients who are scheduled for abdominal surgery, pregnant women or patients taking probiotics or taking antibiotics within 4 weeks prior to installation are also excluded from the protocol.
研究组 & 干预措施
Fecal transplantation
Duodenal transfer of healthy donor fecal suspension
干预措施: fecal suspension (Dietary Supplement)
结局指标
主要结局
Stool microbiota changes
时间窗: up to 28 weeks
abundance of major microbial taxa in fecal transplant post transplantation
次要结局
- Global improvement in IBS symptoms(up to 28 weeks)