Allogenic micobiota-reconstitution (AMR) for the treatment of patients with diarhea-predominant irritable bowel syndrome (IBS-D) - the AMIRA trial

同种异体微生物群重建 (AMR) 用于治疗腹泻型肠易激综合征 (IBS-D) 患者 - AMIRA 试验

• 批准号: 276706135
• 负责人: Professor Dr. Thomas Seufferlein
• 金额: --
• 依托单位: Klinik für Innere Medizin I
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2015
• 资助国家: 德国
• 起止时间: 2014-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/276706135?language=en
• 关键词: Allogenic; micobiota; reconstitution; AMR; treatment

Alterations in gut microbiota are increasingly recognized as a major player in the pathogenesis and pathophysiology of irritable bowel syndrome (ISS). Case reports have shown convincing effects of allogenic microbiome reconstitution (AMR) in patients with IBS. Furthermore, AMR has been established as efficient treatment for recurrent C. difficile infection showing only minor side effects and resulting in durable changes of the gut microbiota. With AMR performed in patients with diarrhea predominant IBS (IBS-D) we aim to reduce related symptoms and to increase patient's well being by reestablishing a healthy intestinal microbiome through infusing stool suspension from healthy donors into the patient's intestine. We will perform a multicenter, randomized, blinded, placebo-controlled trial of AMR in patients with 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 by >105 points. Secondary endpoints include changes in IBS-QOL, short term safety and one year follow up to control lang term effects and safety. The translational program includes changes in, and acceptance of donor microbiome after AMR using 16S rONA sequencing and quantitative diversity analysis. Findings will be correlated with the patient outcome in the primary endpoint. The randomized phase is followed by an open label crossover for non-responders. We expect AMR to significantly reduce IBS-0 related symptoms.

肠道菌群的改变越来越多地被认为是肠易激综合征（ISS）的发病机理和病理生理学的主要参与者。病例报告显示同种异体微生物重建（AMR）对IBS患者的令人信服的影响。此外，AMR已被确定为有效的艰难梭菌感染的有效治疗方法，仅显示较小的副作用，并导致肠道菌群的持久变化。在腹泻主要IBS（IBS-D）患者中进行AMR，我们旨在减少相关症状，并通过从健康的供体中注入粪便悬浮液中的粪便悬挂到患者的肠道中，从而减少患者的健康状况。我们将对根据罗马III标准和IBS-QOL问卷诊断的IBS-D患者进行多中心，随机，盲目的安慰剂对照试验。供体材料的中央供应和质量控制将用于控制偏见。主要终点是提高IBS-SSS> 105分。次要终点包括IBS-QOL的变化，短期安全性和一年的后续操作，以控制Lang期限效果和安全性。翻译程序包括使用16S RONA测序和定量多样性分析的AMR后的变化和接受供体微生物组。发现将与主要终点的患者结局相关。随机相后是无反应器的开放标签交叉。我们预计AMR将显着减少IBS-0相关症状。