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Prebiotics for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction

NCT03987126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-13

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 with spinal cord injury, and who have evidence of neurogenic bladder. Patients will be treated with human milk oligosaccharide (HMO) versus placebo over 12 weeks from start of the investigational medication date (approximately 3 months) to test whether HMO can improve bowel motility in neurogenic bowel and bladder patients. Patients in the placebo arm of the study will be offered participation in the open label portion of the study immediately after their part in the control group is completed, they will receive HMO for 12 weeks. HMO sachets will be administered to determine the safety and efficacy of HMO relative to placebo in improving quality of life of neurogenic bowel and bladder patients by improving bowel motility and function.

Conditions

  • Spinal Cord Injuries
  • Neurogenic Bowel
  • Bladder Dysfunction

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

  • Parkwood Hospital, London, Ontario

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Jeremy P Burton, PhD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2023-06-29
Completion
2023-10-01

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 NCT03987126 on ClinicalTrials.gov