postinfectious/antibiotic-associated Irritable Bowel Syndrome with diarrhea MedDRA version: 8.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome
Conditions
Interventions
Trade Name: Mutaflor
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Ardeypharm GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with postinfectious/antibiotic-associated IBS with diarrhea the typical symptoms should be improved during an 8-week therapie. Treatment with E. coli strain Nissle 1917 (Mutaflor) should be superior to a treatment with placebo. Efficacy will be assessed by the following main objective criterion: Responder rate after 8 weeks of treatment. Responders are defined as having substantial or moderate improvement in IBS symptoms referring to the Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS; Gordon et al., 2003). ;Secondary Objective: Secondary objective criteria are: - responder rate after 4 weeks of treatment - global change of IBS-symtoms after 4 and 8 weeks of treatment - abdominal pain/discomfort - stool consistency - stool frequency - straining - meteorism, flatulence, nausea - quality of life;Primary end point(s): Assessment of the global improvement of IBS-related symptoms (Irritable Bowel Syndrome Global Improvement Scale; Gordon et al., 2003) after 8 weeks of treatment. | — |
Countries
Germany
Outcome results
None listed