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

NCT04095988 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-01-31

No results posted yet for this study

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.

Conditions

  • Diarrhea-predominant Irritable Bowel Syndrome

Interventions

PROCEDURE

Allogeneic microbiota reconstitution

gastroscopic microbiota Infusion (Verum)

PROCEDURE

Placebo-Allogeneic microbiota reconstitution

gastroscopic saline Infusion (placebo)

Sponsors & Collaborators

  • Klinikum Ludwigsburg

    collaborator OTHER

  • Helios Klinikum Krefeld

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Assign International, Berlin, Germany

    collaborator UNKNOWN

  • University of Ulm

    lead OTHER

Principal Investigators

  • Thomas TW Seufferlein, Prof. Dr. · University Hospital Ulm

  • Martin Wagner, Prof. Dr. · University Hospital Ulm

  • Thomas Frieling, Prof. Dr. · Helios Klinikum Krefeld

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-12-31
Completion
2021-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04095988 on ClinicalTrials.gov