PRINCESS - Probiotics to Reduce Infections iN CarE home reSidentS
Research type
Research Study
Full title
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.
IRAS ID
182306
Contact name
Eleri Owen-Jones
Contact email
Sponsor organisation
Cardiff University(Research and Innovation Services)
Duration of Study in the UK
3 years, 3 months, 3 days
Research summary
Care home residents (CHR) are prescribed far more antibiotics than the general population because they get more infections due to weakened immunity, close-proximity living and other multiple illnesses. High antibiotic use increases the risk of resistance to antibiotics. This resistance to antibiotics can spread within care homes and to hospitals and the community. This will get worse with the ageing population in the UK. The commonest reason for CHR to be hospitalised is infections. Infections due to antibiotic resistance are more serious and costly in older people. Reduction in antibiotic use and antibiotic resistance could improve quality of life, save money, and help preserve the usefulness of existing antibiotics.
Other than vaccination and hygiene methods, there are few methods proven to prevent infection in CHR. Probiotics are friendly live bacteria that may give health benefits by improving the immune system of CHR, and reducing spread of harmful bacteria. The study product (probiotic or matching placebo) will be taken as a capsule or sprinkled on food.
Research in CHR is currently lacking. We chose this specific probiotic due to previous research that found probiotics reduced duration of infections and enhanced immune response, including to flu vaccination. Probioitcs are readily available and already used by some. However, evidence for effectiveness in preventing infections is lacking. If positive, the study will identify a cheap, food supplement intervention that may reduce morbidity and loss of dignity. If negative, then that will help people decide whether or not to take them.
The PRINCESS trial will look at a widely available probiotic containing Lactobacillus rhamnosus and Bifidobacterium animalis to see whether it will prevent infections over 12 months. We will assess total days on antibiotics for infections, immune items (including influenza vaccine response), and changes in antibiotic resistance detected in stool samples. We will test to see if probiotics reduce antibiotic administration days by 10% or more.
We will recruit 330 CHR from about 20 care homes in Wales and England (which have around 30 residents) into an individually randomised trial of probiotic vs placebo. We will seek informed consent from care home residents with and without capacity, and consult with their consultee if needed.
Trial participants would be expected to take a once daily dose of study product for 12 months.
Trial participants will provide (optional) blood, saliva and stool samples at Baseline, 3 and 12 months. They will also complete some questionnaires at these same timepoints either by themselves or with the help of someone else (a proxy). A subgroup of trial participants will have additional immunological work done with regards to the routine influenza vaccine. This would be two additional blood samples which would be collected just prior to influenza vaccination, and four weeks after the vaccination, if the trial participant had been taking study product for at least 2 months prior to their influenza vaccination. Additional mechanistic tests will look at responses to pathogenic challenge, but this work will be done on the routine blood samples taken at Baseline and for some, at 12 months.
REC name
Wales REC 3
REC reference
15/WA/0306
Date of REC Opinion
23 Oct 2015
REC opinion
Further Information Favourable Opinion