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

NCT04095988 | Unknown DMC

• 2 other identifiers: AMIRA2016-002550-20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Keywords

Allogeneic microbiota reconstitution; diarrhea-predominant irritable bowel syndrome; microbiome

Outcome Measures

Primary Outcomes (1)

• Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline

  90 days after intervention

Secondary Outcomes (3)

• 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

• Number of participants with treatment related adverse events

  follow-up 1 year

Study Arms (2)

Verum-AMR

EXPERIMENTAL

Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy

Procedure: Allogeneic microbiota reconstitution

Placebo-AMR

PLACEBO COMPARATOR

Patients receiving Placebo(Saline)-Infusion via gastroscopy

Procedure: Placebo-Allogeneic microbiota reconstitution

Interventions

Allogeneic microbiota reconstitution PROCEDURE

gastroscopic microbiota Infusion (Verum)

Verum-AMR

Placebo-Allogeneic microbiota reconstitution PROCEDURE

gastroscopic saline Infusion (placebo)

Placebo-AMR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead
• Klinikum Ludwigsburg: collaborator
• Helios Klinikum Krefeld: collaborator
• Charite University, Berlin, Germany: collaborator
• Assign International, Berlin, Germany: collaborator

Study Sites (2)

Helios Klinikum Krefeld

Krefeld, Germany

Location

Ulm University Hospital

Ulm, Germany

Location

Related Publications (22)

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Study Officials

• Thomas TW Seufferlein, Prof. Dr.

  University Hospital Ulm

  PRINCIPAL INVESTIGATOR

• Martin Wagner, Prof. Dr.

  University Hospital Ulm

  STUDY DIRECTOR

• Thomas Frieling, Prof. Dr.

  Helios Klinikum Krefeld

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Department of Internal Medicine I

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: September 19, 2019
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)