E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
irritable bowel syndrome according to Rome II criteria and small intestinal bacterial overgrowth |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023003 |
|
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 |
To assess the efficacy of Bacillus clausii in the eradication of SIBO small intestinal bacterial overgrowth vs metronidazole, 30 days after the end of treatment. |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of Bacillus clausii vs metronidazole in avoiding recurrence of SIBO, 90 days after the end of the treatment. To assess the efficacy of Bacillus clausii vs metronidazole in improving IBS-related symptoms. To assess the efficacy of Bacillus clausii vs metronidazole in the satisfactory relief of overall IBS symptoms and of abdominal discomfort or pain. To assess the efficacy of Bacillus clausii vs metronidazole in improving IBS quality of life. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Informed consent signed; Subjects aged 18-65; Male and female subjects; IBS patients Rome II criteria with SIBO based on positive lactulose or glucose hydrogen breath test ; Patients able to maintain their usual diet and lifestyle during the course of the study |
|
E.4 | Principal exclusion criteria |
Pregnancy or breast-feeding; Major concomitant diseases including tumours and hepatic and/or renal insufficiency ; Inflammatory bowel diseases ; History of intestinal surgery except cholecystectomy and appendectomy ; Use of antibiotic, laxative, antidiarrhoeic drugs or probiotics medications or dietetic supplements in the last month prior to study entry ; Hypersensibility to the investigational product and reference drug; Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or of any disease that may interfere with the patient successfully completing the trial or the objectives of the trial ; Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential patient; Participation to a trial in the previous three months ; Drug or alcohol abuse; Subjects with unstable personality or not able to be compliant with the study procedures |
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E.5 End points |
E.5.1 | Primary end point(s) |
Eradication rate of SIBO 30 days after the end of the treatment |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |