Can probiotics, inulin and vitamin D3 improve Covid-19 vaccine titres?
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled trial evaluating the influence of probiotic lactobacillus, prebiotic inulin and vitamin D3 on antibody titres post Covid-19 booster 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, 0 days
Research summary
This double-blind, placebo-controlled randomised trial aims to evaluate whether supplementing the diet with a combined lactobacillus probiotic, inulin prebiotic and vitamin D3 capsule could enhance antibody titres post Covid-19 vaccination.
This hypothesis was based on a meta-analysis of 12 RCTs which reported that patients taking mainly lactobacillus probiotics, obtained higher antibody titres after influenza (Flu) vaccination compared to controls. Higher titres after vaccination is known to provide better protection. Other data has linked better vitamin D3 status with greater antibody levels following Flu vaccination. Vitamin D3 deficiency continues to be common across the UK. There is also evidence of beneficial synergy with probiotics increasing vitamin D3 levels and vitamin D3 supporting a healthy gut microbiome. Despite these data, no study has linked probiotic use, vitamin D3 with a better antibody response to a Covid-19 vaccine and hence the rationale for this study.
Prior to a third or fourth Covid-19 vaccination, after written informed consent, volunteers will be randomised to either a nutritional supplement containing 5 lactobacillus probiotic strains, an inulin prebiotic and vitamin D3, or placebo (2:1), for 8 weeks. Anti-covid Spike antibody titres will be measured at baseline and at 8 weeks in each randomised group using the Roche Elecsys® immunoassay, in addition to vitamin D3 levels. The primary statistical end points are the difference in baseline antibody titres and 8 weeks between the two randomised groups.
Data will be collected and processed at the Primrose Research Unit, Bedford Hospital. The trial cohort will include hospital, medical and clerical staff as well patients on follow-up, but not receiving chemotherapy of immunotherapies, and with normal performance status.
REC name
Wales REC 2
REC reference
22/WA/0158
Date of REC Opinion
14 Jul 2022
REC opinion
Further Information Favourable Opinion