Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission

May 23, 2022 updated by: Julajak Limsrivilai, Mahidol University

In the 21st century, the incidence of inflammatory bowel disease (IBD) globally increases. Higher incidence of IBD development may implicate that environmental factors played essential roles in IBD pathogenesis. One of the environmental factors is a westernized diet that contains a high amount of animal protein and a low amount of dietary fiber. This kind of diet can lead to gut microbial dysbiosis and increase susceptibility to IBD. A microbial dysbiosis pattern in IBD is a decrease in microbial diversity and the inversed ratio of local protective and pathologic bacteria. High animal protein was associated with an increased risk of IBD and increased risk of disease relapse meanwhile dietary fiber was associated with IBD risk reduction. A semi-vegetarian diet is a diet with high fiber and low red meat and processed food that may reduce inflammatory activity in IBD. The study in the semi-vegetarian diet in IBD activity is still limited.

This study aimed to evaluate a semi-vegetarian diet's effect in maintaining IBD remission in disease quiescence patients.

Study Overview

Detailed Description

This study is a prospective interventional cohort in clinically quiescence IBD patients in Siriraj Hospital, Mahidol University, Bangkok, Thailand. At enrollment, clinical information, dietary intake, inflammatory markers, and fecal microbiota will be recorded. Dietary intake will be assessed by an experienced nutritionist using pictures of food, a dietary questionnaire, and patient interviewing. The nutritionist advises the participants to consume a semi-vegetarian diet which includes high dietary fiber consumption and low red meat and processed food consumption. All patients will be required to send all pictures of food intake three days in 1 week before every visit, including two weekdays and one weekend. The dietary component will be analyzed using Nutrient calculation computer software INMUCAL-Nutrient V3 database NB1 (Institute of Nutrition, Mahidol University. Nakornpathom. 2013). The study will take 1 year including 6 visits (including baseline, 6th weeks, 18th week, 30th week, 42nd week, 54th week) for each patient. The primary outcome is the effect of increasing fiber diets and decreasing red meat and processed food on maintaining clinical remission in IBD. Secondary outcomes are the effect of modifying diet on change of inflammatory markers, microbiota, and quality of life.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangkok, Thailand, 10700
        • Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with Crohn's disease or Ulcerative colitis
  2. Age ≥ 18 years old
  3. Disease in remission at least 2weeks by following criteria Crohn's disease: Crohn's Disease Activity Index(CDAI) < 150 Ulcerative colitis: Mayo Ulcerative Colitis Subscore ≤ 2
  4. Prednisolone ≤ 15 mg/day for at least 1 month
  5. Stable immunomodulator dosage at least 1 month
  6. Stable biologic agent at least 2 months

Exclusion Criteria:

  1. Patients with Ulcerative colitis with a history of proctocolectomy
  2. Patients with Crohn's disease with bowel stricture
  3. Patients with recently antibiotic usage within 1 month
  4. Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semi-vegetarian diet
All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food.
All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants with clinical relapses
Time Frame: 1 year
Effect of semi-vegetarian food consumption on the rate of participants with clinical relapses assessed by Crohn's disease activity index for Crohn's disease and the clinical Mayo Score or partial Mayo Score for ulcerative colitis. The Crohn's disease activity index ranges from 0 to 1100, a higher score means a worse outcome, and clinical relapse is defined if the score is at least 150 points. The clinical Mayo Score for ulcerative colitis ranges from 0 to 9, a higher score means a worse outcome, and clinical relapse is defined if the score is at least 2 points.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-Reactive Protein (CRP)
Time Frame: 1 year
Effect of semi-vegetarian food consumption on inflammatory markers levels including serum CRP
1 year
fecal calprotectin level
Time Frame: 1 year
Effect of semi-vegetarian food consumption on inflammatory markers levels including fecal calprotectin level
1 year
Fecal microbiota
Time Frame: 1 year
Effect of semi-vegetarian food consumption on changing of fecal microbiota composition and diversity (Shannon's diversity index)
1 year
Quality of life score of SIBDQ
Time Frame: 1 year
Effect of semi-vegetarian food consumption on quality of life: SIBDQ
1 year
Quality of life score of EQ5D3L
Time Frame: 1 year
Effect of semi-vegetarian food consumption on quality of life: EQ5D3L
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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