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Prebiotics for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction

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ClinicalTrials.gov Identifier: NCT03987126
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
The W. Garfield Weston Foundation
St. Joseph's Health Care London
Parkwood Hospital, London, Ontario
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neurogenic Bowel Bladder Dysfunction Dietary Supplement: Human Milk Oligosaccharides (HMO) Other: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One placebo arm and one active treatment arm, participants will be assigned to each arm equally based on their Neurogenic Bowel Dysfunction score.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: No other parties will be masked for the study. A part of the study will be open label.
Primary Purpose: Treatment
Official Title: Use of Novel Human Milk Prebiotics to Improve the Quality of Life for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

Dietary Supplement: Human Milk Oligosaccharides (HMO)
Sachet containing 10 grams of HMO

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

Other: Placebo
Sachet manufactured to mimic 10g of HMO
Other Name: Placebo for HMO




Primary Outcome Measures :
  1. Bowel motility [ Time Frame: 12 weeks ]
    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.

  2. Neurogenic bowel dysfunction score (NBD) [ Time Frame: 12 weeks ]
    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.

  3. Change in method of bowel assistance [ Time Frame: 12 weeks ]
    Medications required, home remedies used, other methods of assistance will be recorded in a study questionnaire.

  4. Duration of bowel routine [ Time Frame: 12 weeks ]
    Measured by the NBD questionnaire.

  5. Episodes of incontinence [ Time Frame: 12 weeks ]
    Will be measured in time between bowel movements by the NBD questionnaire.

  6. Frequency of bowel movements per week [ Time Frame: 12 weeks ]
    Will be measured by the NBD questionnaire.


Secondary Outcome Measures :
  1. Microbiome changes from baseline to end of study [ Time Frame: 12 weeks ]
    Changes in the entire bacterial community from baseline to end of study will be assessed in the lab from faecal and urine samples collected by the participant. The microbes may vary by participant and the study will be looking at which ones present themselves in each case. Of particular interest may be the Enterobacteriaceae like Escherichia coli that cause UTI. Units of measure via culture are colony forming units per g (cfu/g).

  2. Changes in pain [ Time Frame: 12 weeks ]
    A modified International Spinal Cord Injury Pain Basic Dataset version 2.0 questionnaire will be used. The first part of the questionnaire is a scale that ranges from 1-10, with 1 stating their pain is not interfering with their daily activities, and 10 stating extreme interference. The second part is a table that lists different areas of the body and has the participant check off whether they feel pain in the right, middle, or left side of each body area. Pain type will be assessed by the referring clinician and documented in a study CRF.

  3. Change in sleep [ Time Frame: 12 weeks ]
    will be documented in the International Spinal Cord Injury Pain Basic Dataset v2.0 questionnaire. The question scales from 1 - 10, 1 stating that pain has had no interference with the participant getting a good night's sleep, and 10 stating major interference.

  4. Change in mood [ Time Frame: 12 weeks ]
    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.

  5. Quality of Life Measures survey [ Time Frame: 12 weeks ]
    a general quality of life measures survey will be included in the study. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. The cale includes 16 questions, each question can be answered from a range of 1-7 (1 being very unhappy, 7 being very happy) Scores can range from 16 to 112.

  6. Number of participants reporting unexpected adverse events [ Time Frame: 12 weeks ]
    Adverse events will be recorded through case report forms and reported to the principal investigator. Side effects will be assessed using standardized case report forms at each visit. Participants are encouraged to contact the coordinator to report any concerns.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old
  • SCI of at least 3 months duration
  • Neurogenic bowel dysfunction scores of >13

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987126


Contacts
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Contact: Alexandria Roa Agudelo 519-646-6100 ext 42696 Alexandria.RoaAgudelo@sjhc.london.on.ca
Contact: Jeremy P Burton, PhD 519-646-6000 ext 61365 Jeremy.Burton@LawsonResearch.Com

Locations
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Canada, Ontario
Parkwood Institute Not yet recruiting
London, Ontario, Canada, N6C0A7
Contact: Alexandria Roa Agudelo, MLA/T    519-646-6100 ext 42696    Alexandria.RoaAgudelo@sjhc.london.on.ca   
Contact: Eldon Loh, MD    519-685-4080    Eldon.Loh@sjhc.london.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
The W. Garfield Weston Foundation
St. Joseph's Health Care London
Parkwood Hospital, London, Ontario
Investigators
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Principal Investigator: Jeremy P Burton, PhD Lawson Health Research Institute

Additional Information:
Publications:

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03987126     History of Changes
Other Study ID Numbers: 6170
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Neurogenic Bowel
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases