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

University of Ulm

Status: Unknown

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Treatments: Procedure: Allogeneic microbiota reconstitution; Procedure: Placebo-Allogeneic microbiota reconstitution

Study type: Interventional

Funder types: Other

Identifiers

NCT04095988

2016-002550-20 (EudraCT Number)

AMIRA

Details and patient eligibility

About

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.

Full 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

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Verum-AMR

Experimental group

Description:

Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy

Treatment:

Procedure: Allogeneic microbiota reconstitution

Placebo-AMR

Placebo Comparator group

Description:

Patients receiving Placebo(Saline)-Infusion via gastroscopy

Treatment:

Procedure: Placebo-Allogeneic microbiota reconstitution