Recruiting
Early Phase 1

Prebiotic Therapy

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04428190

Conditions

Kidney Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Human Milk Oligosaccharides (HMO)

Placebo

Study Details

Brief 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.

Conditions

Kidney Transplant; Complications

Study ID

NCT04428190

Start date

Feb 23, 2022

Status verified date

Oct, 2023

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Oct 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years of age
  • Inability to give consent
  • Usage of probiotics or other prebiotics.
  • Have had carcinomas during the last 5 years
  • Bowel surgery
  • Crohn ́s disease and other conditions.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Human Milk Oligosaccharides (HMO)

Sachet containing 10 grams of HMO

Placebo

Sachet manufactured to mimic 10g of HMO

Primary outcome measure

  • Short Form Health Survey (SF-36) [ Time Frame: 24 weeks ]
  • Adverse Events [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Mounirah May

519-685-8500mounirah.may@lhsc.on.ca

Jeremy P Burton, PhD

519-646-6000Jeremy.Burton@LawsonResearch.com

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Cadence Baker, MSc

5196858500cadence.baker@lhsc.on.ca

Principal Investigator:

Alp Sener, MD, PhD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Nov 1, 2023

Last verified

Oct, 2023

Keywords

  • kidney
  • kidney transplant
  • prebiotic
  • human milk oligosaccharide
  • HMO
  • renal transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-11-01.