At a glance
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Use of Novel Human Milk Prebiotics to Improve the Quality of Life for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction
In Brief
A Phase 3 clinical trial evaluating Human Milk Oligosaccharides (HMO) and Placebo for Spinal Cord Injuries and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Sachet containing 10 grams of HMO
Sachet manufactured to mimic 10g of HMO