assessing the tolerability of oligosaccharide supplementation in patients with crohn's disease

Conditions: Crohn's Disease

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.

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.

Eligibility criteria:
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) 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.

Keywords: crohn's disease