Abstract: TH-PO0528
Effect of Lacticaseibacillus paracasei Strain Shirota Supplementation on Circulating Endotoxin in People Receiving Haemodialysis: A Randomised Controlled Trial
Session Information
- Dialysis: Novel Therapeutics and Medication Management
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- March, Daniel Scott, University of Leicester, Leicester, England, United Kingdom
- Shigehisa, Akira, Kabushiki Kaisha Yakult Honsha, Minato, Tokyo, Japan
- Abell, Lucy, University of Leicester, Leicester, England, United Kingdom
- Bishop, Nicolette C., Loughborough University, Loughborough, England, United Kingdom
- de Loor, Henriette, KU Leuven, Leuven, Belgium
- Lawday, Daniel Richard, University Hospitals of Leicester NHS Trust, Leicester, England, United Kingdom
- Meijers, Björn Ki, KU Leuven, Leuven, Belgium
- Roberts, Matthew, Loughborough University, Loughborough, England, United Kingdom
- Said, Rahma, University of Leicester, Leicester, England, United Kingdom
- Szeto, Cheuk-Chun, The Chinese University of Hong Kong, Hong Kong, Hong Kong
- Watson, Emma L., University of Leicester, Leicester, England, United Kingdom
- Burton, James, University of Leicester, Leicester, England, United Kingdom
Background
Changes to the intestinal barrier and the translocation of endotoxin into the central circulation may contribute towards cardiovascular risk in people receiving haemodialysis. Therefore, the hypothesis for this trial is that six-months of Lacticaseibacillus paracasei strain Shirota (LcS) supplementation would modify circulating endotoxin compared to placebo.
Methods
The design was a randomised, double-blind, placebo-controlled trial, where adults receiving haemodialysis were randomised (1:1) to either LcS or placebo for six-months. The primary outcome measure for this trial was change in circulating endotoxin between baseline and six-months. The secondary outcomes were p-cresyl sulphate, indoxyl-sulphate, faecal bacterial load and diversity, faecal metabolites, and faecal calprotectin. Initial analysis was performed on a complete case basis with two pre-planned sensitivity analyses conducted to assess implications of missing data and compliance.
Results
Fifty-three participants were recruited to the trial and completed baseline assessment with 44 completing follow-up (n=22 for each group). There was no significant difference between groups in the change in circulating endotoxin from baseline to six-months (Placebo: -0.089 ± 0.196 EU/mL; LcS: -0.087 ± 0.197 EU/mL; mean estimate=0.0064 (-0.061, 0.074); P=0.848). Both intention to treat and per protocol analyses did not change the overall interpretation of the primary outcome. There were no significant changes in any of the secondary outcomes, with the exception of faecal ammonia (P=0.049). There were no associated serious adverse events.
Conclusion
This trial showed that six months of LcS supplementation did not modify circulating levels of endotoxin in the haemodialysis population. Participants tolerated the LcS supplement, with compliance at six-months appearing high.
Funding
- Commercial Support – Yakult Honsha (Japan)