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Prebiotic Therapy to Improve Outcomes of Renal Transplant

NCT04428190 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-01

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Human Milk Oligosaccharides (HMO)

Sachet containing 10 grams of HMO

OTHER

Placebo

Sachet manufactured to mimic 10g of HMO

Sponsors & Collaborators

  • The W. Garfield Weston Foundation

    collaborator UNKNOWN

  • St. Joseph's Health Care London

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Alp Sener, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2024-10-15
Completion
2024-12-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428190 on ClinicalTrials.gov