E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
AAD is diarrhoea occurring in association with antibiotic treatment without an alternative cause. It occurs typically 2-8 weeks after exposure to antibiotics. The frequency of AAD varies markedly between studies according to risk factors such as exposure to broad-spectrum antibiotics, nosocomial infections and host factors such as age, health status, gender. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064065 |
E.1.2 | Term | Prophylaxis against diarrhoea |
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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 |
Primary objectives: to determine the effectiveness and cost-effectiveness of an optimal formulation of lactic acid bacteria and bifidobacteria in preventing or ameliorating AAD and CDD in people aged 65 years and over who are representative of patients admitted to secondary care NHS facilities in the UK and are exposed to oral or intravenous antibiotics |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: to assess the acceptability and adverse effects of the probiotic preparation and the effect of the intervention on quality of life. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• People aged ≥65 years admitted to hospital without diarrhoea and who have been exposed to one or more antibiotics within the last 7 days or are about to start antibiotic treatment |
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E.4 | Principal exclusion criteria |
• People with known immunosuppressive disorder, prosthetic heart valve or active inflammatory bowel disease (the latter defined as requiring specific treatment in the past 12 months) • People with a previous history of adverse reactions to probiotics • Informed consent not granted by patient or their carer(s)
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E.5 End points |
E.5.1 | Primary end point(s) |
Durinig antibiotic treatment and within 8 weeks of stopping antibiotics: a. incidence, severity and duration of AAD b. abdominal symptoms (abdominal pain, bloating, flatus, nausea) c. incidence, severity and uration of CDD and incidence of rrecurrence within the study period d. incidence of PMS, need for colectomy, death e. well-being and quality of life Duration of hospital stay
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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 | Yes |
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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |