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Prebiotic

Human Milk Oligosaccharide (HMO) for Spinal Cord Injury

Phase 3

Waitlist Available

Led By Jeremy P Burton, PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing whether a milk sugar can improve bowel motility in people with neurogenic bowel and bladder. The study will last 12 weeks, and participants will be randomly assigned to either take the milk sugar or a placebo. Everyone will be given the milk sugar at the end of the study.

Eligible Conditions

Spinal Cord Injury
Bladder Dysfunction
Neurogenic Bowel

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bowel motility

Change in method of bowel assistance

Duration of bowel routine

+3 more

Secondary outcome measures

Change in mood

Change in sleep

Changes in pain

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Human Milk Oligosaccharide (HMO)Active Control1 Intervention

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)

Group II: PlaceboPlacebo Group1 Intervention

10 g sachet, self-administered for 3 months. Placebo sachets are identical to the HMO sachets in color, taste, smell, size and shape

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Find a Location

Who is running the clinical trial?

St. Joseph's Health Care LondonOTHER

27 Previous Clinical Trials

2,468 Total Patients Enrolled

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,398 Total Patients Enrolled

Parkwood Hospital, London, OntarioOTHER

6 Previous Clinical Trials

658 Total Patients Enrolled

Media Library

Human Milk Oligosaccharides (HMO) (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03987126 — Phase 3

Spinal Cord Injury Research Study Groups: Placebo, Human Milk Oligosaccharide (HMO)

Spinal Cord Injury Clinical Trial 2023: Human Milk Oligosaccharides (HMO) Highlights & Side Effects. Trial Name: NCT03987126 — Phase 3

Human Milk Oligosaccharides (HMO) (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03987126 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are researchers hoping to discover from this clinical trial?

"The primary outcome of this trial, which will be assessed over approximately 12 weeks, is the Frequency of bowel movements per week. Secondary outcomes include Change in mood, which is defined as will be documented in the International Spinal cord injury Pain Basic Dataset v2.0 questionnaire. The answer will be measured in a scale from 1-10, 1 stating that pain has had no interference with their mood, and 10 stating major interference, Microbiome changes from baseline to end of study, which is defined as Changes in the entire bacterial community from baseline to end of study will be assessed in the lab from faecal and urine samples"

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