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. MedDRA version: 9.1 Level: PT Classification code 10064065 Term: Prophyla
Conditions
Interventions
Trade Name: Proven Plus
Product Name: Proven Plus
Pharmaceutical Form: Powder and solvent for oral solution
Other descriptive name: 4 Strains of lactic
Sponsors
University of Wales Swansea
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: to assess the acceptability and adverse effects of the probiotic preparation and the effect of the intervention on quality of life.;Main Objective: 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; 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 | — |
Countries
United Kingdom
Outcome results
None listed