The Effect of Diet Modification on Clinical Disease Activity, the Gut Microbiome and Immune Responses in Patients With Ulcerative Colitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Simple Clinical Colitis Activity Index (SCCAI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(12 weeks)
- Change in mucosal inflammation measured by fecal calprotectin(12 weeks)
- Fecal microbiota(12 weeks)
- Change in serum marker of inflammation (serum CRP)(12 weeks)
- Change in serum marker of inflammation (serum ferritin)(12 weeks)
Investigators
Deanna Gibson
Associate Professor
University of British Columbia