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

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ClinicalTrials.gov Identifier: NCT02193750
Recruitment Status : Recruiting
First Posted : July 18, 2014
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
The Alfred
Melbourne Health
Information provided by (Responsible Party):
Brian Bressler, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: Placebo Dietary Supplement: Moderate Oligosaccharide Group Dietary Supplement: High Oligosaccharide Group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial
Study Start Date : August 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Placebo Comparator: Placebo
1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
Dietary Supplement: Placebo
1 placebo muesli bar 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)
Dietary Supplement: 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)
Dietary Supplement: High Oligosaccharide Group
1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)




Primary Outcome Measures :
  1. Difference in overall GI symptoms [ Time Frame: 5 days ]
    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.


Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 4 weeks ]
    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.

  2. Fatigue assessment [ Time Frame: 4 weeks ]
    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

  3. Quality of Life Assessment [ Time Frame: 4 weeks ]
    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

  4. Mood Assessment [ Time Frame: 4 weeks ]
    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

  5. Disease Activity Asessment [ Time Frame: 4 weeks ]
    The proportion of participants who relapse, as well as the time to relapse at study completion between groups.

  6. Adherence Assessment [ Time Frame: 4 weeks ]
    Adherence will be estimated and compared between groups at study completion



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193750


Contacts
Contact: Cherry E. Galorport 604-806-9440 cgalorport@gmail.com

Locations
Australia
Department of Gastroenterology Alfred Hospital Recruiting
Melbourne, Australia
Contact: Julie Hogg    +61 3 90760182      
Sub-Investigator: Peter Gibson, MD         
Sub-Investigator: Jane Muir, PhD         
Sub-Investigator: Jacqueline Barrett, PhD         
Canada, British Columbia
GI Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Cherry Galorport    604-806-9440    cgalorport@gmail.com   
Principal Investigator: Brian Bressler, MD         
Sub-Investigator: Ashley Charlebois, RD, MsC         
Sub-Investigator: Amee Manges, PhD         
Sub-Investigator: Greg Rosenfeld, MD         
Sub-Investigator: Neal Shahidi, MD         
Sponsors and Collaborators
University of British Columbia
The Alfred
Melbourne Health
Investigators
Principal Investigator: Brian Bressler, MD Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda
Principal Investigator: Peter Gibson, MD Department of Gastroenterology Alfred Hospital, Melbourne, Australia

Publications of Results:

Other Publications:
Responsible Party: Brian Bressler, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02193750     History of Changes
Other Study ID Numbers: H14-01420
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Brian Bressler, University of British Columbia:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Levan
Antineoplastic Agents