Probiotics for antibiotic-associated diarrhoea (including Clostridium difficile) in care homes: providing incidence data on antibiotic-associated diarrhoea in care homes and evaluating care homes as a setting to conduct complex studies/drug trials

The PAAD study: Probiotics for Antibiotic-Associated Diarrhoea (including Clostridium difficile) in care homes: establishing the platform

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN79548440

Enrollment

270

Registered

2010-07-06

Start date

2010-10-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-associated diarrhoea in the elderly, living in care homes Signs and Symptoms

Interventions

Nine care homes in South Wales and the care home service users (residents) will be recruited for Stage 1. The main part of Stage 1 is a 12-month prospective observational study that aims to collect da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Service users who are/have been admitted to the care home for >24 hours 2. Planned admission to care home of one month or more (excludes short-term respite care) 3. Written informed consent/assent provided

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Main observational study 1.1. To conduct prospective systematic ascertainment of the incidence of AAD in care homes 1.2. To allow an appraisal of the estimated sample size for a randomised controlled trial (RCT) in Stage 2	—

Secondary

Measure	Time frame
1. Main observational study 1.1. To conduct prospective systematic ascertainment of antibiotic use in care homes 1.2. To estimate the risk of AAD overall and from particular antibiotics in care home settings 1.3. To identify barriers and implementation issues in conducting a trial of AAD prevention/amelioration in a care home setting 2. Sub-studies 2.1. Sub Study 1. Prevalence: 1.1.1 To determine the prevalence of asymptomatic C. difficile carriage in service users within selected care homes. 2.2 Sub Study 2. Probiotic Feasibility and Acceptability: 2.2.1. To test the acceptability and feasibility of administering probiotics in a small number of service users 2.2.2. To pilot and develop trial procedures including modelling consent procedures 2.2.3. To develop a training package for nursing home personnel to implement the trial 2.3. Sub Study 3. Qualitative: 2.3.1. To explore the ethical and practical issues of consent and assent, particularly the topic of advanced consent, for elderly residents who may/may not have capacity to consent	—

Measure

Time frame

1. Main observational study 1.1. To conduct prospective systematic ascertainment of antibiotic use in care homes 1.2. To estimate the risk of AAD overall and from particular antibiotics in care home settings 1.3. To identify barriers and implementation issues in conducting a trial of AAD prevention/amelioration in a care home setting 2. Sub-studies 2.1. Sub Study 1. Prevalence: 1.1.1 To determine the prevalence of asymptomatic C. difficile carriage in service users within selected care homes. 2.2 Sub Study 2. Probiotic Feasibility and Acceptability: 2.2.1. To test the acceptability and feasibility of administering probiotics in a small number of service users 2.2.2. To pilot and develop trial procedures including modelling consent procedures 2.2.3. To develop a training package for nursing home personnel to implement the trial 2.3. Sub Study 3. Qualitative: 2.3.1. To explore the ethical and practical issues of consent and assent, particularly the topic of advanced consent, for elderly residents who may/may not have capacity to consent

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026