Use of Novel Human Milk Prebiotics to Improve the Quality of Life for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction

Who is this study for? Patients with spinal cord injury with bowel and bladder dysfunction
What treatments are being studied? Human Milk Oligosaccharides
Status: Completed
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Phase 3
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.

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

• 18 years old

• SCI of at least 3 months duration

• Neurogenic bowel dysfunction scores of \>10 OR 4 or less bowel movements per week, OR requires a suppository to have a bowel movement

Locations
Other Locations
Canada
Parkwood Institute
London
Time Frame
Start Date: 2021-01-27
Completion Date: 2023-10-01
Participants
Target number of participants: 30
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 already been shown to very specifically modulate intestinal bacteria, namely the beneficially viewed bifidobacteria, in clinical studies in adults. Modulating bifidobacteria increases the levels of specific short chain fatty acids (SCFAs), such as butyrate, propionate and acetate.These SCFAs have been shown to stimulate colonic sodium and fluid absorption and exert proliferative effects on the colonocyte in experimental animal studies since the 1990s (Scheppach 1994). Therefore, increasing their levels would lead to an improvement in intestinal motility, as has been summarised previously (Koh 2016)
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, Parkwood Hospital, London, Ontario, St. Joseph's Health Care London
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov