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Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02093780
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Levinus Dieleman, University of Alberta

Brief Summary:
In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a role in decreasing the risk of UC development or management of UC-related symptoms or relapse. Since the primary outcome of interest is the relapse rate in two groups, disease status will be assessed monthly using appropriate tools. In order to find out the underlying mechanisms that will relate the proposed diet to decreased flare rate, some laboratory evaluations, which are mainly markers of inflammation or are related to gut microbiome will be conducted. In the present study, the investigators will also perform state-of-the art metabolomics tests, in order to study how the dietary changes will change the end metabolites. In addition, the investigators will be able to explore if metabolomic profile of participants can predict future UC relapse. This study will last for 6 months from baseline wherein all the study subjects will receive appropriate dietary instructions in addition to their stable doses of maintenance drug therapy.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Behavioral: Alberta Anti-inflammatory diet Behavioral: Canada's Food Guide Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Dietary Approach to Reduce the Frequency of Relapse in Ulcerative Colitis Patients: a Randomized Controlled Clinical Trial Study
Study Start Date : March 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alberta Anti-inflammatory Diet
Patients randomized into this group will receive a dietary menu plan that contains anti-inflammatory foods/nutrients that have been shown to be effective in the management of IBD in previous studies. The main aim of this diet will be to increase dietary intakes of prebiotics/probiotics, omega 3 fatty acids, fiber (soluble), antioxidants and decrease dietary intake of red and processed meat.
Behavioral: Alberta Anti-inflammatory diet
Patients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months.

Active Comparator: Canada's Food Guide Diet

Patients that have been randomized into this group will receive simple dietary recommendations based on the Canada's Food Guide. The details of Canada's Food Guide can be available here:

http://www.hc-sc.gc.ca/fn-an/food-guide-aliment/index-eng.php

Behavioral: Canada's Food Guide Diet
Patients randomized to Canada's Food Guide diet will receive counseling by certified dietitian for 6 months and will design their own diet following Canada's Food Guide.




Primary Outcome Measures :
  1. Patient relapse rate [ Time Frame: 6 months ]
    Relapse is defined as the total partial Mayo score exceeds 2. Partial Mayo score represents a sum of the subject's symptoms for rectal bleeding and stool frequency, as well as a physician global assessment score, each of them scored from 0 to 3.


Secondary Outcome Measures :
  1. Time to relapse [ Time Frame: 6 months ]
    Time from start until clinical relapse (outcome 1)

  2. Quality of Life improvement [ Time Frame: 6 months ]
    Improvement of Quality of Life

  3. change in mucosal inflammation, measured by fecal calprotectin [ Time Frame: 6 months ]
    Mucosal inflammation, measured by fecal calprotectin at baseline, months 1, 3, 6 or at relapse

  4. changes in partial Mayo score from baseline [ Time Frame: 6 months ]
    Partial Mayo disease activity score at the baseline and monthly, and at a relapse



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have Ulcerative Colitis in clinical remission (partial Mayo score of less than 2)
  • Fecal calprotectin of more than 150 microgram/g
  • Patients on oral 5-ASA drugs and/or Azathioprine or 6-mercaptopurine as long as the dose has been stable for 2 weeks (between 2-2.4 gram daily for oral 5-ASA) or 2 months (for azathioprine or 6-mercaptopurine).
  • Participants must be generally healthy besides having UC
  • Must be able to communicate in English.
  • Live in the Edmonton Area.

Exclusion Criteria:

  • Use of prednisone (or steroid equivalent) at the time of enrollment.
  • Use of anti-TNF drugs within 3 months of enrollment.
  • Use of antibiotics (washout period of at least 2 weeks is required).
  • Pregnancy or lactation.
  • History of colectomy.
  • Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen).
  • Active gastrointestinal infection.
  • Severe psychiatric disorder.
  • Unable or unwilling to consent

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): NCT02093780


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Levinus A Dieleman, MD, PhD University of Alberta
Publications:
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Responsible Party: Levinus Dieleman, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02093780    
Other Study ID Numbers: Pro00035413
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents