Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial
Official title:
Allogeneic Microbiota-reconstitution (AMR) for the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome - the AMIRA Trial
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.
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
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