Status:
TERMINATED
Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
The Alfred
Melbourne Health
Conditions:
Crohn's Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Subjects age \>/= 19 years with the diagnosis of CD for \>/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (\</=4 points) and C-reactive protein (\<5 mg/L) will be recruite...
Eligibility Criteria
Inclusion
- age \>/= 19 years
- diagnosed with CD for \>/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (\</= 4 points) and C-reactive protein (\<5mg/L)
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02193750
Start Date
August 1 2015
End Date
September 1 2020
Last Update
April 30 2021
Active Locations (2)
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1
Department of Gastroenterology Alfred Hospital
Melbourne, Australia
2
GI Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6