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

Ulcerative Colitis Clinical Trial

Official title:

The Effect of Diet Modification on Clinical Disease Activity, the Gut Microbiome and Immune Responses in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053713
• Other study ID #: H16-03300
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.
• Habitual diet (control)
Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.

Locations

Country	Name	City	State
Canada	University of British Columbia - Okanagan	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Foundation for Dietetic Research (CFDR)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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;7:24. doi: 10.1186/1479-7364-7-24. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simple Clinical Colitis Activity Index (SCCAI)	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.	Change from baseline to week 12
Secondary	Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12.	12 weeks
Secondary	Fecal microbiota	Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks	12 weeks
Secondary	Change in mucosal inflammation measured by fecal calprotectin	Change in mucosal inflammation will be measured by fecal calprotectin at baseline and week 12	12 weeks
Secondary	Change in serum marker of inflammation (serum CRP)	Change in markers of inflammation will be measured by serum CRP	12 weeks
Secondary	Change in serum marker of inflammation (serum ferritin)	Change in markers of inflammation will be measured by serum ferritin	12 weeks