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

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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.