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The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03053713
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2017
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Deanna Gibson, University of British Columbia

Brief Summary:
The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Behavioral: Mediterranean diet pattern Behavioral: Habitual diet (control) Not Applicable

Detailed Description:

Few studies have found a single dietary factor as being protective or detrimental against inflammatory bowel disease (IBD), therefore novel diet approaches for the prevention and treatment of IBD are urgently needed. The Mediterranean Diet Pattern (MDP) is associated with improvements in health status and inflammatory markers in healthy individuals and rodent models of colitis. Reductions in inflammatory biomarkers and a "normalization" of the gut microbiota have been shown in patients with Crohn's disease following a MDP. To date, no studies have examined the effect of MDP on disease activity, inflammatory markers or the effects on the microbiome in ulcerative colitis (UC).

This study will examine the effects of a MDP taken by patients with UC on 1) symptoms, clinical and quality of life endpoints and 2) on gut microbiome and fecal immune biomarkers. One hundred subjects and two subjects with UC will be randomly allocated to follow a MDP for 12 weeks or their usual diet (controls). Upon initiation, throughout and completion of each diet, symptoms, clinical and quality of life endpoints will be monitored. Fecal samples will be collected to assess pH, short-chain fatty acid concentrations, bacterial abundance and diversity.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Using a randomized, parallel treatment design, the effects of the Mediterranean diet pattern on symptoms, clinical disease activity, gut microbiome and fecal biomarkers in stable UC patients in remission will be examined. Using this design, we will compare the habitual diet (taken as a "control" diet) to the Mediterranean diet pattern taken by UC patients over a 12-week period.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Diet Modification on Clinical Disease Activity, the Gut Microbiome and Immune Responses in Patients With Ulcerative Colitis
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mediterranean Diet Pattern
Mediterranean diet pattern x 12 weeks.
Behavioral: Mediterranean diet pattern
Subjects assigned to the Mediterranean diet pattern arm will receive nutrition advice from a Registered Dietitian (RD). The RD will meet with the subjects (in-person) to provide diet education at randomization, week 3 and week 6 of the intervention. Phone and e-mail follow-up will occur at week 2 and week 9 to provide cooking tips, recipes, videos and answer questions.

Placebo Comparator: Habitual Diet
Habitual diet (control) x 12 weeks.
Behavioral: Habitual diet (control)
Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.




Primary Outcome Measures :
  1. Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: Change from baseline to week 12 ]
    The SCCAI is a symptom-based disease activity index that uses six clinical parameters: daytime and nocturnal bowel frequency, urgency, amount of blood in the stool, well-being and extraintestinal manifestations. A reduction of SCCAI >1.5 is considered clinically significant and SCCAI score of <4 is indicative of remission.


Secondary Outcome Measures :
  1. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 12 weeks ]
    Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12.

  2. Fecal microbiota [ Time Frame: 12 weeks ]
    Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks

  3. Change in mucosal inflammation measured by fecal calprotectin [ Time Frame: 12 weeks ]
    Change in mucosal inflammation will be measured by fecal calprotectin at baseline and week 12

  4. Change in serum marker of inflammation (serum CRP) [ Time Frame: 12 weeks ]
    Change in markers of inflammation will be measured by serum CRP

  5. Change in serum marker of inflammation (serum ferritin) [ Time Frame: 12 weeks ]
    Change in markers of inflammation will be measured by serum ferritin



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative Colitis in clinical remission (partial Mayo score 0-1)
  • Taking oral 5-ASA, methotrexate, azathioprine or 6-mecaptopurine as long as there have been no changes in dosage for 2 months prior to the start of the study
  • Generally healthy besides having UC
  • Agree not to use any dietary supplements, herbal treatments, prebiotics, probiotics or diet therapies within three weeks of the onset of the trial or during the study

Exclusion Criteria:

  • Using prednisone (or steroid equivalent) or biologics (i.e., infliximab, adalimumab, vedolizumab) at the time of enrollment
  • Using antibiotics two weeks prior to or anytime during the study period
  • Pregnancy, lactation or desire to become pregnant during the study period because we do not know if or how an unborn baby/fetus could be harmed
  • History of colectomy or extensive colonic resection or disease is limited to the rectum
  • Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen)
  • Active gastrointestinal infection (e.g., C. difficile infection)
  • Severe psychiatric disorder
  • Unable or unwilling to consent
  • Unable to comply with study requirements
  • Presence of alcohol or drug abuse

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): NCT03053713


Locations
Canada, British Columbia
University of British Columbia - Okanagan
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia
Canadian Foundation for Dietetic Research (CFDR)
Investigators
Principal Investigator: Deanna L Gibson, PhD University of British Columbia - Okanagan

Publications:
Responsible Party: Deanna Gibson, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03053713     History of Changes
Other Study ID Numbers: H16-03300
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deanna Gibson, University of British Columbia:
Mediterranean diet pattern
nutrition
diet intervention
disease activity
intestinal microbiome
inflammatory bowel disease

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases