The effect of probiotic supplementation (YAKULT)
Research type
Research Study
Full title
Daily intake of Lactobacillus casei Shirota (LcS) modulates intestinal permeability and decreases circulating levels of endotoxin that associate with both cardiovascular and all-cause mortality in haemodialysis (HD) patients.
IRAS ID
274507
Contact name
James O Burton
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Haemodialysis patients have high rates of heart disease, hospitalisation and death. Inflammation is a non-traditional factor unique to the condition of haemodialysis patients and is strongly related to these poor clinical outcomes. There is increasing evidence that changes to the gut wall and the microbes that inhabit the gut may play a role in this inflammation in this population. There are a number of unique factors related to the condition, the hameodialysis process, and dietary restrictions placed on this population that may cause these changes. Interventions that reduce such changes in these patients are somewhat limited, however there is some emerging evidence from smaller studies that the consumption of probiotics may be effective in combating these changes. A need for larger, well conducted randomised controlled trials testing the efficacy of probiotic supplementation in haemodialysis patients has been recognised and this trial aims to begin addressing this question. Therefore, this trial will randomise haemodialysis patients to either 6 months of probiotic supplementation (Yakult) or a matched placebo. At baseline, we will measure gut-derived markers of cardiovascular risk, markers of gut health, and inflammation in the blood, We will ask participants about their quality of life, and gastrointestinal health using questionnaires, in addition we will extract information around hospital admissions, infections, and antibiotic consumption from medical records. During the trial we will also record participant compliance with the product. At 6 months the measurements that are taken from participants at baseline will be repeated. It is hoped that the results from this trial will help to inform new treatments for the reduction of cardiovascular risk in the haemodialysis population.
Lay summary of study results: This study found that taking a probiotic supplement (Yakult) for six-months did not change blood markers of inflammation in people with kidney disease undergoing haemodialysis treatment. We also didn’t find changes in other blood markers related to gut health after taking the probiotic. However, we did observe an increase in a faecal marker linked to digestion following supplementation. Most participants tolerated the probiotic well, with the majority still taking it after six months. Lastly, there was no evidence that the supplement caused any harm to people with kidney disease.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0068
Date of REC Opinion
3 Apr 2020
REC opinion
Further Information Favourable Opinion