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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT02193750
• Date of registration: 16/07/2014
• Prospective Registration: Yes
• Primary sponsor: University of British Columbia
• Public title: Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease
• Scientific title: Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial
• Date of first enrolment: August 2015
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02193750
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Australia, Canada

Contacts

• Name: Brian Bressler, MD
• Affiliation: Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda

• Name: Peter Gibson, MD
• Affiliation: Department of Gastroenterology Alfred Hospital, Melbourne, Australia

Key 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.



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Dietary Supplement: Moderate Oligosaccharide Group

Dietary Supplement: High Oligosaccharide Group

Dietary Supplement: Placebo

Primary Outcome(s)

Difference in overall GI symptoms [Time Frame: 5 days]

Secondary Outcome(s)

Quality of Life Assessment [Time Frame: 4 weeks]

Tolerability assessment including overall gastrointestinal symptoms and specific symptoms [Time Frame: 4 weeks]

Adherence Assessment [Time Frame: 4 weeks]

Fatigue assessment [Time Frame: 4 weeks]

Mood Assessment [Time Frame: 4 weeks]

Disease Activity Asessment [Time Frame: 4 weeks]

Secondary ID(s)

H14-01420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Alfred

Melbourne Health