Prebiotic Therapy to Improve Outcomes of Renal Transplant

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

An investigator initiated pilot study: two arm, double blind, placebo controlled, randomized, group of approximately 60 patients undergoing a kidney transplant. Participants will be treated with human milk oligosaccharide (HMO) prebiotic versus placebo over 12 weeks from start of the investigational medication date (approximately 3 months) to test whether HMO can improve renal transplant outcomes. Participants will be followed up for 3 months after after they complete the treatment portion of the study. HMO sachets will be administered to determine the safety and efficacy of HMO relative to placebo in improving renal transplant outcomes in patients by reducing delayed graft function and side effects from post transplant therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age and over receiving a kidney transplant.

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Mounirah May
mounirah.may@lhsc.on.ca
519-685-8500
Backup
Jeremy P Burton, PhD
Jeremy.Burton@LawsonResearch.com
519-646-6000
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2024-12-15
Participants
Target number of participants: 60
Treatments
Active_comparator: Human Milk Oligosaccharide (HMO)
10 g sachet, self-administered for 3 months.~2'-O-fucosyllactose and lacto-N-neotetraose, novel human milk oligosaccharide (HMO) sugars have been shown to stimulate the production of short chain fatty acids, especially propionate. Propionate has been shown to be important in attenuating hypertrophy, fibrosis, vascular dysfunction and hypertension (Bartolomaeus H et al 2019Mar12) and extremely important for the gut kidney axis (Li L et al 2017Dec11).
Placebo_comparator: Placebo
10 g sachet, self-administered for 3 months.~Placebo sachets are identical to the HMO sachets in color, taste, smell, size and shape
Related Therapeutic Areas
Sponsors
Collaborators: The W. Garfield Weston Foundation, St. Joseph's Health Care London, London Health Sciences Centre
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov