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

Primary Purpose

Inflammatory Bowel Diseases, Calprotectin, Fecal Microbiota

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Semi-vegetarian diet and increase fiber consumption
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases focused on measuring Vegetarian diet, inflammatory bowel diseases

Eligibility Criteria

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

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

Sites / Locations

  • Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Semi-vegetarian diet

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of participants with clinical relapses
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2021
Last Updated
May 23, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04835727
Brief Title
Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission
Official Title
Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Calprotectin, Fecal Microbiota, Vegetarian Diet
Keywords
Vegetarian diet, inflammatory bowel diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective interventional cohort study in patients with clinically quiescent IBD. At enrollment, clinical information, dietary intake, inflammatory markers, and fecal microbiota were recorded. Dietary intake was assessed by an experienced nutritionist using pictures of food, a dietary questionnaire, and patient interviewing. The nutritionist advised the participants to intake a semi-vegetarian diet and increase dietary fiber consumption. The changes in clinical symptoms, dietary intake, inflammatory markers, and fecal microbiota were recorded in each visit for 1 year.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semi-vegetarian diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Semi-vegetarian diet and increase fiber consumption
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of participants with clinical relapses
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
C-Reactive Protein (CRP)
Description
Effect of semi-vegetarian food consumption on inflammatory markers levels including serum CRP
Time Frame
1 year
Title
fecal calprotectin level
Description
Effect of semi-vegetarian food consumption on inflammatory markers levels including fecal calprotectin level
Time Frame
1 year
Title
Fecal microbiota
Description
Effect of semi-vegetarian food consumption on changing of fecal microbiota composition and diversity (Shannon's diversity index)
Time Frame
1 year
Title
Quality of life score of SIBDQ
Description
Effect of semi-vegetarian food consumption on quality of life: SIBDQ
Time Frame
1 year
Title
Quality of life score of EQ5D3L
Description
Effect of semi-vegetarian food consumption on quality of life: EQ5D3L
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Crohn's disease or Ulcerative colitis Age ≥ 18 years old 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 Prednisolone ≤ 15 mg/day for at least 1 month Stable immunomodulator dosage at least 1 month Stable biologic agent at least 2 months Exclusion Criteria: Patients with Ulcerative colitis with a history of proctocolectomy Patients with Crohn's disease with bowel stricture Patients with recently antibiotic usage within 1 month Pregnant patients
Facility Information:
Facility Name
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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