NCT03987126

Prebiotics for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction

Completed Phase 3 Last updated 13 December 2023

What this trial tests

Phase 3 trial testing Human Milk Oligosaccharides (HMO) in Spinal Cord Injuries in 30 participants. Completed in 1 October 2023.

Timeline

27 January 2021

Primary endpoint
29 June 2023

1 October 2023

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	27 January 2021
Primary completion	29 June 2023
Estimated completion	1 October 2023
Sites	1 location across Canada

Drugs / interventions tested

• Human Milk Oligosaccharides (HMO)
• Placebo

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Neurogenic Bowel — all drugs for Neurogenic Bowel →
• Bladder Dysfunction — all drugs for Bladder Dysfunction →

Sponsor

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

Who can join

18 and older, any sex, with Spinal Cord Injuries or Neurogenic Bowel. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases.
   Todd CL, Johnson EE, Stewart F, Wallace SA, et al · · 2024 · cited 3× · PMID 39470206 · DOI 10.1002/14651858.cd002115.pub6