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

January 30, 2020 updated by: Thomas Seufferlein, University of Ulm

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Krefeld, Germany
        • Helios Klinikum Krefeld
      • Ulm, Germany
        • Ulm University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Verum-AMR
Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy
Procedure: Allogeneic microbiota reconstitution
gastroscopic microbiota Infusion (Verum)
PLACEBO_COMPARATOR: Placebo-AMR
Patients receiving Placebo(Saline)-Infusion via gastroscopy
Procedure: Placebo-Allogeneic microbiota reconstitution
gastroscopic saline Infusion (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
Time Frame: 90 days after intervention
90 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline
Time Frame: 90 days and 1 year after intervention
90 days and 1 year after intervention
Changes and acceptance of donor microbiome (16S rDNA-analysis)
Time Frame: 90 days after intervention
16S rDNA-analysis for microbiome biodiversity, correlation to IBS-Symptom Severity Score (IBS-SSS)
90 days after intervention
Number of participants with treatment related adverse events
Time Frame: follow-up 1 year
follow-up 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

Charite University, Berlin, Germany
Klinikum Ludwigsburg
Helios Klinikum Krefeld
Assign International, Berlin, Germany

Investigators

  • Principal Investigator: Thomas TW Seufferlein, Prof. Dr., University Hospital Ulm
  • Study Director: Martin Wagner, Prof. Dr., University Hospital Ulm
  • Principal Investigator: Thomas Frieling, Prof. Dr., Helios Klinikum Krefeld

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

September 18, 2019

First Posted (ACTUAL)

September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMIRA
  • 2016-002550-20 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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