CompletedNot Applicable

The Effect of Probiotic Supplementation

United Kingdom60 participantsStarted 2020-09-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

Blood circulating endotoxin concentration

Timeframe: 6 months

Trial details

NCT IDNCT04390347

SponsorUniversity of Leicester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-24

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