Clinical trial NCT03053713: The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis
Official title: The Effect of Diet Modification on Clinical Disease Activity, the Gut Microbiome and Immune Responses in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Mediterranean diet pattern
nutrition
diet intervention
disease activity
intestinal microbiome
inflammatory bowel disease
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for Dietetic Research (CFDR)
First posted: 2017-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: Change from baseline to week 12
Secondary outcomes:
measure: Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: 12 weeks
measure: Fecal microbiota
timeFrame: 12 weeks
measure: Change in mucosal inflammation measured by fecal calprotectin
timeFrame: 12 weeks
measure: Change in serum marker of inflammation (serum CRP)
timeFrame: 12 weeks
measure: Change in serum marker of inflammation (serum ferritin)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia - Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia- Okanagan
name: Deanna L Gibson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeCoffe D, Quin C, Gill SK, Tasnim N, Brown K, Godovannyi A, Dai C, Abulizi N, Chan YK, Ghosh S, Gibson DL. Dietary Lipid Type, Rather Than Total Number of Calories, Alters Outcomes of Enteric Infection in Mice. J Infect Dis. 2016 Jun 1;213(11):1846-56. doi: 10.1093/infdis/jiw084. Epub 2016 Apr 10.
citation: Strisciuglio C, Giugliano F, Martinelli M, Cenni S, Greco L, Staiano A, Miele E. Impact of Environmental and Familial Factors in a Cohort of Pediatric Patients With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):569-574. doi: 10.1097/MPG.0000000000001297.
citation: Marlow G, Ellett S, Ferguson IR, Zhu S, Karunasinghe N, Jesuthasan AC, Han DY, Fraser AG, Ferguson LR. Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients. Hum Genomics. 2013 Nov 27;7(1):24. doi: 10.1186/1479-7364-7-24.