Clinical trial NCT04095988: Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Official title: Allogeneic Microbiota-reconstitution (AMR) for the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome - the AMIRA Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Keywords: Allogeneic microbiota reconstitution
diarrhea-predominant irritable bowel syndrome
microbiome
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Klinikum Ludwigsburg
name: Helios Klinikum Krefeld
name: Charite University, Berlin, Germany
name: Assign International, Berlin, Germany
First posted: 2019-09-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
timeFrame: 90 days after intervention
Secondary outcomes:
measure: Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline
timeFrame: 90 days and 1 year after intervention
measure: Changes and acceptance of donor microbiome (16S rDNA-analysis)
timeFrame: 90 days after intervention
measure: Number of participants with treatment related adverse events
timeFrame: follow-up 1 year
Other outcomes:
Locations:
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld
city: Ulm
country: Germany
facility: Ulm University Hospital
Study officials:
affiliation: University Hospital Ulm
name: Thomas TW Seufferlein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ulm
name: Martin Wagner, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Helios Klinikum Krefeld
name: Thomas Frieling, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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