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

Not Applicable

Completed

Interventions: Behavioral: Habitual diet (control)
Behavioral: Mediterranean diet pattern

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Habitual Diet	Habitual diet (control)	Habitual diet (control) x 12 weeks.
Mediterranean Diet Pattern	Mediterranean diet pattern	Mediterranean diet pattern x 12 weeks.

Primary Outcome Measures

Name	Time	Method
Simple Clinical Colitis Activity Index (SCCAI)	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

Name	Time	Method
Change in serum marker of inflammation (serum ferritin)	12 weeks	Change in markers of inflammation will be measured by serum ferritin
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	12 weeks	Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12.
Change in mucosal inflammation measured by fecal calprotectin	12 weeks	Change in mucosal inflammation will be measured by fecal calprotectin at baseline and week 12
Fecal microbiota	12 weeks	Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks
Change in serum marker of inflammation (serum CRP)	12 weeks	Change in markers of inflammation will be measured by serum CRP

Locations (1): University of British Columbia - Okanagan
🇨🇦
Kelowna, British Columbia, Canada