Diarrhea-predominant Irritable Bowel Syndrome
Conditions
Keywords
Allogeneic microbiota reconstitution, diarrhea-predominant irritable bowel syndrome, microbiome
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
Interventions
PROCEDUREAllogeneic microbiota reconstitution
gastroscopic microbiota Infusion (Verum)
PROCEDUREPlacebo-Allogeneic microbiota reconstitution
gastroscopic saline Infusion (placebo)
Sponsors
Klinikum Ludwigsburg
Helios Klinikum Krefeld
Charite University, Berlin, Germany
Assign International, Berlin, Germany
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline | 90 days after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 16S rDNA-analysis for microbiome biodiversity, correlation to IBS-Symptom Severity Score (IBS-SSS) |
| Number of participants with treatment related adverse events | follow-up 1 year | — |
Countries
Germany
Outcome results
None listed