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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
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
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
Tolerability assessment including overall gastrointestinal symptoms and specific symptoms
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Fatigue assessment
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Quality of Life Assessment
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Mood Assessment
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Disease Activity Asessment
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Adherence Assessment
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
Sex
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
Accrual to date
Final
24
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/ct2/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. No abstract available.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02193750