Specialty: Infectious diseases and microbiology Infections and Infestations
Conditions
Interventions
Participants are randomised to one of two groups via an online system which uses the method of minimisation, with a random component set at 80%. There are two minimisation variables: the care home at
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 65 years or older 2. Currently living in a care home setting (residential, nursing or mixed) 3. Participant is willing and able to give informed consent for participation in the trial OR if the participant lacks capacity, a consultee is willing to complete a consultee declaration form
Exclusion criteria
Exclusion criteria: 1. Is known to be immunocompromised (requiring immunosuppressants, long term high dose oral, intramuscular or intravenous steroids) 2. Is currently taking regular probiotics and is not willing to adapt to trial protocol 3. Is a temporary care home resident (i.e. less than 1 month of planned transitional/respite residential care) 4. Death is thought to be imminent 5. Lactose intolerant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cumulative antibiotic administration days for all cause infections over 12 months 2. Total number of days of systemic antibiotic administration as recorded in care home medical records and discharge summaries if the participant is admitted to hospital, over 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 01/11/2018: 1. Cumulative Antibiotic Administration Days (CAAD) for five sub-categories of Common Infectious Diseases (Respiratory Tract Infection, Urinary Tract Infection, skin, Gastrointestinal Infections and unexplained fever); number, site, duration (mean and cumulative) of infection over 12 months as measured by data recorded at regular intervals by research nurses from care home records. 2. Antibiotic consumption as measured by data recorded at regular intervals by RN from care home records over 12 months 3. Hospitalisation rate as measured by data recorded at regular intervals by RN from care home records over 12 months 4. Mortality as measured by data recorded at regular intervals by RN from care home records over 12 months 5. Health Utility as measured using the EQ-5D at baseline, 3 months and 12 months 6. Wellbeing is measured using the ICECAP-O at baseline, 3 months and 12 months 7. Full blood count (FBC) as measured by laboratory analysis of blood samples taken at baseline and 12 months 8. Vitamin D levels as measured by laboratory analysis of blood samples taken at baseline and 12 months 9. Immunology - Patient’s cytokine and chemokine response in whole blood samples stimulated ex-vivo by Toll Like Receptors TLR2 and TLR4 as measured by laboratory analysis of samples taken at baseline and 12 months 10. Measurement of plasma cytokines and chemokines in plasma and whole blood; and measurement of monocyte and neutrophil phagocytosis of E.coli 11. Antimicrobial resistance (AMR) as measured by Culture and antibiotic sensitivity of Gram-negative Enterobacteriaceae and Vancomycin resistant enterococci (VRE) from stool sample at baseline and 12 months 12. Presence of probiotic bacteria Lactobacillus rhamnosus, LGG and Bifidobacterium animalis subsp. lactis, BB-12, plus presence of (antimicrobial resistant) AMR bacteria and C. difficile in stool is measured by laboratory analysis of stool samples taken at baseline, 3 months | — |
Countries
United Kingdom, Wales
Outcome results
None listed