The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

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.
    

Intervention name(s): Mediterranean diet pattern; Habitual diet (control)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.
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
Keywords: Mediterranean diet pattern; nutrition; diet intervention; disease activity; intestinal microbiome; inflammatory bowel disease