E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
postinfectious/antibiotic-associated Irritable Bowel Syndrome with diarrhea |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060845 |
E.1.2 | Term | Diarrhea predominant irritable bowel syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |