Probiotics to reduce infections in care home residents

INTERVENTION: 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 which the participant is resident, and the participant’s gender. Intervention arm: Once daily oral probiotic (Lactobacillus rhamnosus, LGG and Bifidobacterium animalis subsp. lactis, BB‐12) for twelve months. Placebo arm: Once daily oral placebo for twelve months. Two follow‐up visits will take place, at 3 and 12 months. CONDITION: Specialty: Infectious diseases and microbiology ; Infections and Infestations PRIMARY OUTCOME: 1. Cumulative antibiotic administration days for all cause infections over twelve 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 twelve months 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 SECONDARY OUTCOME: 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 twelve 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 twelve months; 5. Health Utility as measured using the EQ‐5D at baseline, three months and twelve months; 6. Wellbeing is measured using the ICECAP‐O at baseline, three months and twelve months; 7. Full blood count (FBC) as measured by laboratory analysis of blood samples taken at baseline and twelve months ; 8. Vitamin D levels as measured by laboratory analysis of blood samples taken at baseline and twelve 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 twelve months; 10. Blood ‐ Modified expression of Toll Like Receptors (TLR) as measured in circulating white blood cells from whole blood samples taken at baseline and twelve months; 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 twelve 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, three months and twelve months; 13. Presence of oral Candida species in saliva is measured by semi‐quantitiative laboratory analysis of saliva samples taken at baseline, three months and twelve months; 14. Influenza vaccine response ‐ Haemagglutination inhibition assay and antibody titers at two points during participation: one immediately prior to the vaccine being administered and one 28 days post vaccine administration