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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mediterranean diet pattern
Habitual diet (control)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Mediterranean diet pattern, nutrition, diet intervention, disease activity, intestinal microbiome, inflammatory bowel disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia - Okanagan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mediterranean Diet Pattern

Habitual Diet

Arm Description

Mediterranean diet pattern x 12 weeks.

Habitual diet (control) x 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2017
Last Updated
May 19, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Foundation for Dietetic Research (CFDR)
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1. Study Identification

Unique Protocol Identification Number
NCT03053713
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Foundation for Dietetic Research (CFDR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Mediterranean diet pattern, nutrition, diet intervention, disease activity, intestinal microbiome, inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet Pattern
Arm Type
Active Comparator
Arm Description
Mediterranean diet pattern x 12 weeks.
Arm Title
Habitual Diet
Arm Type
Placebo Comparator
Arm Description
Habitual diet (control) x 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet pattern
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Habitual diet (control)
Intervention Description
Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.
Primary Outcome Measure Information:
Title
Simple Clinical Colitis Activity Index (SCCAI)
Description
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.
Time Frame
Change from baseline to week 12
Secondary Outcome Measure Information:
Title
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Description
Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12.
Time Frame
12 weeks
Title
Fecal microbiota
Description
Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks
Time Frame
12 weeks
Title
Change in mucosal inflammation measured by fecal calprotectin
Description
Change in mucosal inflammation will be measured by fecal calprotectin at baseline and week 12
Time Frame
12 weeks
Title
Change in serum marker of inflammation (serum CRP)
Description
Change in markers of inflammation will be measured by serum CRP
Time Frame
12 weeks
Title
Change in serum marker of inflammation (serum ferritin)
Description
Change in markers of inflammation will be measured by serum ferritin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanna L Gibson, PhD
Organizational Affiliation
University of British Columbia- Okanagan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia - Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27067195
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.
Results Reference
background
PubMed Identifier
27306105
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.
Results Reference
background
PubMed Identifier
24283712
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.
Results Reference
background

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

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