A double-blind placebo controlled trial to evaluate the efficacy of probiotics (Lactobacillus rhamnosus, LGG and Bifidobacterium animalis subsp. lactis, BB-12) in reducing antibiotic administration for infection in care home residents

Cardiff University0 sites310 target enrollmentJuly 20, 2016

Overview

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31227535/ protocol (added 09/06/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32633801/ results (added 08/07/2020) 2021 Other publications in https://doi.org/10.3389/fragi.2021.599084 Relationships Between Age, Frailty, Length of Care Home Residence and Biomarkers of Immunity and Inflammation in Older Care Home Residents in the United Kingdom (added 06/08/2024) 2021 Results article in https://doi.org/10.3389/fimmu.2021.643321 (added 06/08/2024) 2021 Results article in https://doi.org/10.3310/eme08070 (added 06/08/2024)

Registry

who.int

Start Date

July 20, 2016

End Date

July 1, 2019

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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

•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