- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04835727
Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission
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
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand, 10700
- Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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.
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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.
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-Reactive Protein (CRP)
Time Frame: 1 year
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Effect of semi-vegetarian food consumption on inflammatory markers levels including serum CRP
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1 year
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fecal calprotectin level
Time Frame: 1 year
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Effect of semi-vegetarian food consumption on inflammatory markers levels including fecal calprotectin level
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1 year
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Fecal microbiota
Time Frame: 1 year
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Effect of semi-vegetarian food consumption on changing of fecal microbiota composition and diversity (Shannon's diversity index)
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1 year
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Quality of life score of SIBDQ
Time Frame: 1 year
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Effect of semi-vegetarian food consumption on quality of life: SIBDQ
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1 year
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Quality of life score of EQ5D3L
Time Frame: 1 year
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Effect of semi-vegetarian food consumption on quality of life: EQ5D3L
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si 063/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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