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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bowel motility
Timeframe: 12 weeks
Neurogenic bowel dysfunction score (NBD)
Timeframe: 12 weeks
Change in method of bowel assistance
Timeframe: 12 weeks
Duration of bowel routine
Timeframe: 12 weeks
Episodes of incontinence
Timeframe: 12 weeks
Frequency of bowel movements per week
Timeframe: 12 weeks