E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clostridium difficile infection |
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MedDRA Classification |
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 define the prevalence of Clostridium difficile carriage in hospitalized patients greater the 50 years of age including patients in long-term care settings
· To establish whether the consumption of probiotic strain Bifidobacterium infantis 35624 affects the carriage rate and clinical history of Clostridium difficile disease.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
To be considered eligible for enrolment into the study, subjects must 1. Be greater than 50 years of age, 2. Be in generally good health as determined by the investigator
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E.4 | Principal exclusion criteria |
Subjects will be excluded from the study if they meet any of the below criteria; 1. Are less than 50 years of age 2. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological) or a condition which contraindicates, in the investigators judgement, entry to the study. 3. Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding which, in the Investigator’s judgment, contraindicates participation in the study. 4. Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results. 5. Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial. 6. Patients may not be receiving treatment involving experimental drugs. 7. If the patient has been in a recent experimental trial, must be not less than 30 days prior to this study. 8. Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator’s judgment, contraindicates participation in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
-To define the prevalence of Clostridium difficile carriage in hospitalized patients greater the 50 years of age including patients in long-term care settings
-To establish whether the consumption of probiotic strain Bifidobacterium infantis 35624 affects the carriage rate and clinical history of Clostridium difficile disease.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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 | 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
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End of Trial: When last subject has completed final study visit. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |