Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Not Applicable

• Conditions: Diarrhea-predominant Irritable Bowel Syndrome
• Interventions: Procedure: Placebo-Allogeneic microbiota reconstitution; Procedure: Allogeneic microbiota reconstitution

• Registration Number: NCT04095988
• Lead Sponsor: University of Ulm

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-06-14
• Study Start: 2016-09
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31
• Primary Completion: 2020-12
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• dementia
• abdominal surgery in the last months
• antibiotic therapy in the last 3 months
• pregnancy
• linguistic barrier for informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-AMR	Placebo-Allogeneic microbiota reconstitution	Patients receiving Placebo(Saline)-Infusion via gastroscopy
Verum-AMR	Allogeneic microbiota reconstitution	Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy

Primary Outcome Measures

Name	Time	Method
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline	90 days after intervention

Secondary Outcome Measures

Name	Time	Method
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	16S rDNA-analysis for microbiome biodiversity, correlation to IBS-Symptom Severity Score (IBS-SSS)
Number of participants with treatment related adverse events	follow-up 1 year

Trial Locations

Locations (2)

Ulm University Hospital; 🇩🇪 Ulm, Germany

Helios Klinikum Krefeld; 🇩🇪 Krefeld, Germany