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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Diseases, Calprotectin, Fecal Microbiota, Vegetarian Diet

Intervention / Treatment
-----------------
* Other: Semi-vegetarian diet and increase fiber consumption


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-vegetarian diet<br>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. | Other: Semi-vegetarian diet and increase fiber consumption<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vegetarian diet, inflammatory bowel diseases