NCT02193750

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

Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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 recruited from two academic hospitals and affiliated gastroenterology outpatient clinics (St. Paul's Hospital, Vancouver, British Columbia, Canada; Alfred Hospital, Melbourne, Victoria, Australia). The study is a randomized, double-blind, placebo-controlled trial that consist of a 2-week run-in period followed by a 4-week study period. Prior to study entry, a screening visit will be required for all potential participants. If a participant meets the inclusion criteria, they will be randomized to either a placebo (0.55 g total fructans/GOS), a moderate oligosaccharide group (3.25 g total fructans/GOS) or a high oligosaccharide group (5.43 g total fructans/GOS) through a computed-generated scheme within each respective center. During the run-in period, enrolled subjects will undergo the following: 1) Laboratory analyses (CBC, routine biochemistry, CRP and fecal calprotectin); 2) Stool collection for fecal calprotectin analysis; 3) tolerability assessment including overall gastrointestinal symptoms and specific symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) utilizing a 100mm visual analogue scale (VAS, 0 = no symptoms; 100 = worst symptoms ever experienced); 4) fatigue assessment utilizing a multi-dimensional fatigue impact scale (FIS); 5) health-related quality of life (HRQOL) assessment utilizing the Short Form 36-Item Health Survey (SF-36) and 6) Mood assessment utilizing the Spielberger State-Trait Personality Inventory (STPI). Participants will also meet with a registered dietitian to quantify baseline oligosaccharide consumption by completing a prospective 5-day diet diary alongside a validated food frequency questionnaire (FFQ), the Monash University Comprehensive Nutritional Assessment Questionnaire (CNAQ) that assesses oligosaccharide intake in addition to the usual nutrients \[49\]. Once the initial dietary assessment is complete, participants will begin up-titration of their oligosaccharide supplementation in a step-wise fashion until they reach their required daily amounts defined by their treatment group allocation. Once this is achieved, they will enter the 4 weeks of treatment or at time of relapse. Participants will undergo re-assessment during the study period at 2 weeks (Visit #3), and at study completion (Visit #4). If a participant undergoes a CD flare during the run-in period, they will be withdrawn from the study. The end point of the study will be at 4 weeks of treatment or at time of relapse.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
DIETARY_SUPPLEMENT	Moderate Oligosaccharide Group	1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
DIETARY_SUPPLEMENT	High Oligosaccharide Group	1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2014-07-18
• Last updated: 2021-04-30

Locations

2 sites across 2 countries: Australia, Canada