The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03053713|
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2017
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Behavioral: Mediterranean diet pattern Behavioral: Habitual diet (control)||Not Applicable|
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|
|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)|
|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 :||September 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
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.
- 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.
- 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.
- Fecal microbiota [ Time Frame: 12 weeks ]Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks
- 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
- Change in serum marker of inflammation (serum CRP) [ Time Frame: 12 weeks ]Change in markers of inflammation will be measured by serum CRP
- Change in serum marker of inflammation (serum ferritin) [ Time Frame: 12 weeks ]Change in markers of inflammation will be measured by serum ferritin
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
|Canada, British Columbia|
|University of British Columbia - Okanagan|
|Kelowna, British Columbia, Canada, V1V 1V7|
|Principal Investigator:||Deanna L Gibson, PhD||University of British Columbia - Okanagan|