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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02193750
Registration number
NCT02193750
Ethics application status
Date submitted
16/07/2014
Date registered
18/07/2014
Date last updated
30/04/2021
Titles & IDs
Public title
Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease
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Scientific title
Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial
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Secondary ID [1]
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H14-01420
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - Moderate Oligosaccharide Group
Other interventions - High Oligosaccharide Group
Placebo Comparator: Placebo - 1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
Experimental: Moderate Oligosaccharide Group - 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
Experimental: High Oligosaccharide Group - 1 intervention muesli bar and 1 serving intervention muesli per day (5.43 total fructans/GOS)
Other interventions: Placebo
1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
Other interventions: Moderate Oligosaccharide Group
1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
Other interventions: High Oligosaccharide Group
1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference in overall GI symptoms
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Assessment method [1]
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The primary outcome will be the difference in overall gastrointestinal symptoms quantified by the VAS, at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups.
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Timepoint [1]
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5 days
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Secondary outcome [1]
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Tolerability assessment including overall gastrointestinal symptoms and specific symptoms
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Assessment method [1]
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Secondary outcomes concerning tolerability will include differences in the individual gastrointestinal symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) quantified by the VAS at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups.
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Timepoint [1]
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4 weeks
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Secondary outcome [2]
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Fatigue assessment
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Assessment method [2]
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Secondary endpoints concerning differences in the scores of the overall FIS (fatigue impact scale) and sub-categories (physical, cognitive, psychosocial) at study completion compared to baseline in all 3 study groups
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Timepoint [2]
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4 weeks
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Secondary outcome [3]
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Quality of Life Assessment
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Assessment method [3]
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Secondary endpoints concerning differences in physical components summary (PCS) and the mental component summary (MSC) scores at study completion compared to baseline in all 3 study groups respectively
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Timepoint [3]
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4 weeks
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Secondary outcome [4]
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Mood Assessment
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Assessment method [4]
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Secondary endpoints concerning mood that will include differences in state anxiety, state curiosity, state anger, and state depression scores of the STPI at study completion compared to baseline in all 3 study groups respectively
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Timepoint [4]
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4 weeks
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Secondary outcome [5]
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Disease Activity Asessment
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Assessment method [5]
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The proportion of participants who relapse, as well as the time to relapse at study completion between groups.
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Timepoint [5]
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4 weeks
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Secondary outcome [6]
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Adherence Assessment
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Assessment method [6]
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Adherence will be estimated and compared between groups at study completion
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Timepoint [6]
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4 weeks
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Eligibility
Key inclusion criteria
- 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)
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Minimum age
19
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2020
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Department of Gastroenterology Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of British Columbia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Melbourne Health
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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 and tolerable therapeutic intervention in patients with Crohn's disease (CD)
in remission.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02193750
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Trial related presentations / publications
Talley NJ, Abreu MT, Achkar JP, Bernstein CN, Dubinsky MC, Hanauer SB, Kane SV, Sandborn WJ, Ullman TA, Moayyedi P; American College of Gastroenterology IBD Task Force. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011 Apr;106 Suppl 1:S2-25; quiz S26. doi: 10.1038/ajg.2011.58. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Brian Bressler, MD
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Address
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Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02193750
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