E. coli Stamm Nissle 1917 zur Behandlung des postinfektiösen/Antibiotika-assoziierten Reizdarmsyndroms mit Diarrhö E. coli strain Nissle 1917 for the treatment of post-infectious/antibiotic-associated irritable bowel syndrome with diarrhea - Mut-IBS-Study

• Conditions: postinfectious/antibiotic-associated Irritable Bowel Syndrome with diarrhea; MedDRA version: 8.1Level: LLTClassification code 10060845Term: Diarrhea predominant irritable bowel syndrome

• Registration Number: EUCTR2006-000500-16-DE
• Lead Sponsor: Ardeypharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-24
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

- age between 18 and 55 years
- signed informed consent form by the patient
- fulfilling the ROME-III-criteria
- IBS with diarrhea
- post-infectious/antibiotic-associated IBS
- flexible sigmoidoscopy or colonoscopy within the past 5 years
- sonography of the abdomen within the past 5 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General exclusion criteria:
- participation in a clinical trial within the past 30 days
- simultaneous participation in another clinical trial
- insufficient contraception in women of childbearing age
- pregnancy and/or nursing period
- insufficient cooperativeness of the patient
- limited legal competence of the patient
- alcohol or drug abuse
- known hypersensitivity against any of the components of the trial medication

Anamnestic exclusion criteria:
- absence of current IBS-symptoms
- infectious diarrhea
- functional diarrhea
- inflammatory bowel disease
- known diverticular disease
- known celiac disease
- known lactose intolerance
- major surgeries on the colon
- clinically relevant gastrointestinal stenoses
- anamnestic data indicating an organic disease (red flags”)
- administration of anti-depressants
- administration of E. coli strain Nissle 1917 within the past 3 months
- serious concomitant diseases of
the heart
the liver
the kidney
- reasons which in the investigator’s judgment argue against inclusion of the patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified