Status:
COMPLETED
The Effect of Probiotic Supplementation
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
Loughborough University
Yakult Honsha Co., LTD
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a double-blind randomised controlled trial where participants will be randomised to either twice daily 65ml of Lactobacillus casei Shirota for six months or a matched placebo.
Detailed Description
Intervention The intervention product (Yakult) (supplied as fermented milk) and placebo will be delivered in sealed pots of 65 mL with date stamped expiry. Yakult contains Lactobacillus casei Shirota...
Eligibility Criteria
Inclusion
- Be a prevalent haemodialysis patient (\>3 months)
- Age 18 years or older
- Able and willing to give informed consent
- Sufficient understanding of English to understand the patient information sheet and complete questionnaires
Exclusion
- Aged \<18 years
- Unable or unwilling to give informed consent
- Unlikely to remain on haemodialysis for the 6-month duration of the trial (e.g. planned transplantation)
- Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota
- Any of the following conditions:
- Documented allergy or intolerance to milk protein (e.g. lactose intolerance, milk/dairy allergy)
- Autoimmune disease (e.g. systemic lupus erythematosus)
- Inflammatory bowel disease (e.g. Crohn's colitis)
- Diagnosed infectious illness within the previous 30-days
- Prescribed any of the following medication:
- Antibiotics or anti-viral medications within the previous 30-days
- Steroids or other immunosuppressive agents -
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04390347
Start Date
September 21 2020
End Date
December 31 2023
Last Update
March 21 2025
Active Locations (1)
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1
University Hospitals of Leicester
Leicester, Leicestershire, United Kingdom