Status:
UNKNOWN
Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
Klinikum Ludwigsburg
Helios Klinikum Krefeld
Conditions:
Diarrhea-predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04095988
Start Date
September 1 2016
End Date
May 1 2021
Last Update
January 31 2020
Active Locations (2)
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1
Helios Klinikum Krefeld
Krefeld, Germany
2
Ulm University Hospital
Ulm, Germany