Prebiotics for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction

NCT03987126 | Completed Phase 3

• 1 other identifier: 6170
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Neurogenic Bowel; Bladder Dysfunction

Outcome Measures

Primary Outcomes (6)

• Bowel motility

  Improvement of 25-30% in our study population in the neurogenic bowel function of our intervention study group after treatment, will be measured by the Neurogenic Bowel dysfunction score. Neurogenic Bowel Dysfunction score will be measured by a symptom-based questionnaire that scores 10 variables to attain a total score between 0 and 47. It includes frequency of bowel movements, time of defecation, evacuation and incontinence.

  12 weeks

• Neurogenic bowel dysfunction score (NBD)

  The change in this assessment from baseline to end of study will help determine the improvement in bowel motility. It is a symptom-based questionnaire that scores 10 variables to attain a total score between 0 and 47. It includes frequency of bowel movements, time of defecation, evacuation and incontinence.

  12 weeks

• Change in method of bowel assistance

  Medications required, home remedies used, other methods of assistance will be recorded in a study questionnaire.

  12 weeks

• Duration of bowel routine

  Measured by the NBD questionnaire.

  12 weeks

• Episodes of incontinence

  Will be measured in time between bowel movements by the NBD questionnaire.

  12 weeks

• Frequency of bowel movements per week

  Will be measured by the NBD questionnaire.

  12 weeks

Secondary Outcomes (6)

• Microbiome changes from baseline to end of study

  12 weeks

• Changes in pain

  12 weeks

• Change in sleep

  12 weeks

• Change in mood

  12 weeks

• Quality of Life Measures survey

  12 weeks

Study Arms (2)

Human Milk Oligosaccharide (HMO)

ACTIVE COMPARATOR

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)

Dietary Supplement: Human Milk Oligosaccharides (HMO)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Human Milk Oligosaccharides (HMO) DIETARY_SUPPLEMENT

Sachet containing 10 grams of HMO

Human Milk Oligosaccharide (HMO)

Placebo OTHER

Sachet manufactured to mimic 10g of HMO

Also known as: Placebo for HMO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Inability to understand and respond to the provided questionnaires
• Carcinomas during the last 5 years
• Bowel surgery
• Crohn ́s disease or other bowel conditions

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The W. Garfield Weston Foundation: collaborator
• St. Joseph's Health Care London: collaborator
• Parkwood Hospital, London, Ontario: collaborator

Study Sites (1)

Parkwood Institute

London, Ontario, N6C0A7, Canada

Location

Related Publications (12)

• Taweel WA, Seyam R. Neurogenic bladder in spinal cord injury patients. Res Rep Urol. 2015 Jun 10;7:85-99. doi: 10.2147/RRU.S29644. eCollection 2015.

  PMID: 26090342 BACKGROUND

• Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord. 2006 Oct;44(10):625-31. doi: 10.1038/sj.sc.3101887. Epub 2005 Dec 13.

  PMID: 16344850 BACKGROUND

• Christensen P, Bazzocchi G, Coggrave M, Abel R, Hultling C, Krogh K, Media S, Laurberg S. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006 Sep;131(3):738-47. doi: 10.1053/j.gastro.2006.06.004.

  PMID: 16952543 BACKGROUND

• Christensen P, Bazzocchi G, Coggrave M, Abel R, Hulting C, Krogh K, Media S, Laurberg S. Outcome of transanal irrigation for bowel dysfunction in patients with spinal cord injury. J Spinal Cord Med. 2008;31(5):560-7. doi: 10.1080/10790268.2008.11754571.

  PMID: 19086714 BACKGROUND

• Tulsky DS, Kisala PA, Tate DG, Spungen AM, Kirshblum SC. Development and psychometric characteristics of the SCI-QOL Bladder Management Difficulties and Bowel Management Difficulties item banks and short forms and the SCI-QOL Bladder Complications scale. J Spinal Cord Med. 2015 May;38(3):288-302. doi: 10.1179/2045772315Y.0000000030.

  PMID: 26010964 BACKGROUND

• Elison E, Vigsnaes LK, Rindom Krogsgaard L, Rasmussen J, Sorensen N, McConnell B, Hennet T, Sommer MO, Bytzer P. Oral supplementation of healthy adults with 2'-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. Br J Nutr. 2016 Oct;116(8):1356-1368. doi: 10.1017/S0007114516003354. Epub 2016 Oct 10.

  PMID: 27719686 BACKGROUND

• Koh A, De Vadder F, Kovatcheva-Datchary P, Backhed F. From Dietary Fiber to Host Physiology: Short-Chain Fatty Acids as Key Bacterial Metabolites. Cell. 2016 Jun 2;165(6):1332-1345. doi: 10.1016/j.cell.2016.05.041.

  PMID: 27259147 BACKGROUND

• Al KF, Bisanz JE, Gloor GB, Reid G, Burton JP. Evaluation of sampling and storage procedures on preserving the community structure of stool microbiota: A simple at-home toilet-paper collection method. J Microbiol Methods. 2018 Jan;144:117-121. doi: 10.1016/j.mimet.2017.11.014. Epub 2017 Nov 16.

  PMID: 29155236 BACKGROUND

• Bao Y, Al KF, Chanyi RM, Whiteside S, Dewar M, Razvi H, Reid G, Burton JP. Questions and challenges associated with studying the microbiome of the urinary tract. Ann Transl Med. 2017 Jan;5(2):33. doi: 10.21037/atm.2016.12.14.

  PMID: 28217698 BACKGROUND

• Reid G, Burton JP. Urinary incontinence: Making sense of the urinary microbiota in clinical urology. Nat Rev Urol. 2016 Oct;13(10):567-8. doi: 10.1038/nrurol.2016.182. Epub 2016 Sep 20. No abstract available.

  PMID: 27644934 BACKGROUND

• Whiteside SA, Razvi H, Dave S, Reid G, Burton JP. The microbiome of the urinary tract--a role beyond infection. Nat Rev Urol. 2015 Feb;12(2):81-90. doi: 10.1038/nrurol.2014.361. Epub 2015 Jan 20.

  PMID: 25600098 BACKGROUND

• Scheppach W. Effects of short chain fatty acids on gut morphology and function. Gut. 1994 Jan;35(1 Suppl):S35-8. doi: 10.1136/gut.35.1_suppl.s35.

  PMID: 8125387 BACKGROUND

Related Links

• The first canadian national atlas of Spinal Cord Injury Rehabilitation from a collaborative community of practice to provide the best care to individuals living with the consequences of spinal cord injury.

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Interventions

Health Maintenance Organizations

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Officials

• Jeremy P Burton, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: No other parties will be masked for the study. A part of the study will be open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One placebo arm and one active treatment arm, participants will be assigned to each arm equally based on their Neurogenic Bowel Dysfunction score.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 14, 2019
• Study Start: January 27, 2021
• Primary Completion: June 29, 2023
• Study Completion: October 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)