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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02193750




Registration number
NCT02193750
Ethics application status
Date submitted
16/07/2014
Date registered
18/07/2014
Date last updated
9/03/2018

Titles & IDs
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
Secondary ID [1] 0 0
H14-01420
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in overall GI symptoms - 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.
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
Tolerability - 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.
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Fatigue assessment - 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
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Quality of Life Assessment - 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
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Mood Assessment - 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
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Disease Activity Asessment - The proportion of participants who relapse, as well as the time to relapse at study completion between groups.
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Adherence Assessment - Adherence will be estimated and compared between groups at study completion
Timepoint [6] 0 0
4 weeks

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)
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Gastroenterology Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia

Funding & Sponsors
Primary sponsor type
Other
Name
University of British Columbia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melbourne Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02193750
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. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Brian Bressler, MD
Address 0 0
Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cherry E. Galorport
Address 0 0
Country 0 0
Phone 0 0
604-806-9440
Fax 0 0
Email 0 0
cgalorport@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02193750