Allogeneic Microbiota-reconstitution (AMR) for the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome - the AMIRA Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
研究概览
简要总结
The investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with diarrhea predominant-IBS (IBS-D) diagnosed according to Rome III criteria and the IBS-QOL questionnaire. Central supply and quality control of donor material will be used to control bias.
Primary endpoint is improvement of IBS-SSS (Severity Score System) compared to baseline. Secondary endpoints include changes in IBS-QOL, short term safety and one year follow up to control long term effects, safety and changes in and acceptance of donor microbiome after AMR using16S rDNA sequencing and quantitative diversity analysis.
详细描述
This study assesses allogeneic microbiota reconstitution (AMR) as novel treatment to improve symptoms and quality of life of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
The investigators will perform a prospective multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with IBS-D diagnosed according to Rome III criteria and the IBS-QOL questionnaire.
The experimental intervention is an infusion of donor feces via gastroscopy. The placebo intervention is an infusion of sterile saline via gastroscopy.
Planned number of patients included in the study: 42 patients Planned per-protocol group: 33 patients
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
- •written informed consent
- •irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria
- •Symptoms for > 1 year before study inclusion
- •persisting symptoms > 1 year before study inclusion
- •relevant symptoms with reduced Quality of Life (IBS-QOL < 60 Points)
- •no specific findings in gastroscopy and colonoscopy with biopsies in the last 2 years
排除标准
- •chronic inflammatory diseases
- •gastrointestinal infectious diseases
- •microscopic colitis
- •celiac disease
- •diarrhea caused by fructose- or lactose intolerance
- •gastrointestinal malignancies or intestinal polyps
- •irritable bowel syndrome of other type than IBS-D
- •bile acid diarrhea
- •constipation
- •symptoms caused by other diseases than IBS-D
- •abdominal surgery in the last months
- •antibiotic therapy in the last 3 months
- •pregnancy
- •linguistic barrier for informed consent
结局指标
主要结局
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
时间窗: 90 days after intervention
次要结局
- Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline(90 days and 1 year after intervention)
- Changes and acceptance of donor microbiome (16S rDNA-analysis)(90 days after intervention)
- Number of participants with treatment related adverse events(follow-up 1 year)
研究者
Thomas Seufferlein
Director Department of Internal Medicine I
University of Ulm