Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease

Study Purpose

The investigators hypothesize that a novel method for oligosaccharide supplementation, in the form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS), will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD) in remission.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - age >/= 19 years - diagnosed with CD for >/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (Exclusion Criteria: - unable to provide informed consent; - have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular disease; - confirmed diagnosis of celiac disease, or have suspected celiac disease and are following a gluten-free diet to manage symptoms with an elevated screening anti-tissue transglutaminase antibody test; - significant complications of CD which includes a history of extensive colonic resection, including subtotal or total colectomy, history of >/= 3 small bowel resections or received a diagnosis of short bowel syndrome, current ileostomy, colostomy or ileal-anal pouch, or a fixed symptomatic intestinal stenosis; - antibiotic use in the 4 weeks prior to study start; - use of any rectal preparations in the 2 weeks prior to study start; - use of any non-steroidal anti-inflammatory drugs in the 2 weeks prior to study start; - use of commercial probiotic supplements in the 4 weeks prior to study start - change in CD therapy in the 4 weeks prior to study start (excluding steroid taper, however steroid dosing must be stable for 2 weeks prior to study start); - recently been adhering to a novel dietary intervention for alternative health issues within the last 4 weeks prior to study start.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02193750
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of British Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brian Bressler, MDPeter Gibson, MD
Principal Investigator Affiliation Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC CanandaDepartment of Gastroenterology Alfred Hospital, Melbourne, Australia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOther
Overall Status Recruiting
Countries Australia, Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

Subjects age >/= 19 years with the diagnosis of CD for >/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (

Contact a Trial Team

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International Sites

Melbourne, Australia

Status

Recruiting

Address

Department of Gastroenterology Alfred Hospital

Melbourne, ,

Site Contact

Julie Hogg

cgalorport@gmail.com

+61 3 90760182

GI Clinic, St. Paul's Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6

Site Contact

Cherry Galorport

cgalorport@gmail.com

604-806-9440

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