Can probiotics and vitamin D improve covid vaccine titres?
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled trial evaluating the influence of vitamin D and gut health promotion on antibody titres post Covid-19 vaccination
IRAS ID
306628
Contact name
Rajeev Kumar
Contact email
Sponsor organisation
Bedfordshire Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
2021-002826-26, EudraCT
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The hypothesis for this double-blind, placebo-controlled randomised trial is that lifestyle advice to promote gut health, supplemented by a lactobcillus probiotic, inulin prebiotic and vitamin D3 capsule enhances antibody titres post Covid-19 vaccination.
Twelve scientifically robust randomised studies report that patients taking, mainly lactobacillus probiotics with prebiotics in supplement form, had higher antibody titres after Influenza vaccination compared to controls. Other data also suggest that better vitamin D status has also been associated with greater seroprotective responses to Influenza vaccination. Likewise, several studies have suggested that exercise around the time of the vaccine enhances response. Despite these reported benefits, to date, no study has linked probiotic use, vitamin D or exercise with a better antibody response to a Covid-19 vaccine and hence the rationale for this study.
Prior to, or at the time of a Covid-19 vaccination and after written, informed consent, participants will be randomised to either a nutritional supplement containing 5 lactobacillus probiotic strains, an inulin prebiotic and vitamin D3, or placebo (2:1), for 12 weeks. Anti-SARS-CoV-2 Spike antibody titres will be measured at week 12 using the Roche Elecsys® Anti-SARS-CoV-2 S immunoassay. Primary statistical end points are the difference in baseline antibody titres at 12 weeks. The secondary statistical end point is the level of exercise recorded by participants in relation to antibody titre recorded with the MRC Recent Physical Activity Questionnaire (RPAQ) at 6 weeks.
Data will be collected and processed at Bedford Hospital Research Department. Information for the trial will be provided to GP's practices and hospital colleagues. Any individual who is registered at Bedfordshire Hospitals NHS Foundation Trust and interested in participating, will be asked to contact the trials unit before their vaccine.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/LO/0175
Date of REC Opinion
8 Mar 2022
REC opinion
Unfavourable Opinion