Inflammatory Bowel DiseasesNCT04835727
Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission
A study testing Semi-vegetarian diet and increase fiber consumption in people with Inflammatory Bowel Diseases and Calprotectin, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Calprotectin, Fecal Microbiota
- What is being tested?
- Semi-vegetarian diet and increase fiber consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 21 Jan 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
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.
Read the 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.
- Being tested
- Semi-vegetarian diet and increase fiber consumption
- Keywords
- Vegetarian diet, inflammatory bowel diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-vegetarian diet and increase fiber consumptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Semi-vegetarian diet | Experimental | 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. Receives: Other: Semi-vegetarian diet and increase fiber consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
C-Reactive Protein (CRP)
Effect of semi-vegetarian food consumption on inflammatory markers levels including serum CRP
Measured: 1 year
fecal calprotectin level
Effect of semi-vegetarian food consumption on inflammatory markers levels including fecal calprotectin level
Measured: 1 year
Fecal microbiota
Effect of semi-vegetarian food consumption on changing of fecal microbiota composition and diversity (Shannon's diversity index)
Measured: 1 year
Quality of life score of SIBDQ
Effect of semi-vegetarian food consumption on quality of life: SIBDQ
Measured: 1 year
Quality of life score of EQ5D3L
Effect of semi-vegetarian food consumption on quality of life: EQ5D3L
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Jan 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julajak Limsrivilai, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835727
- Sponsor's protocol ID
- Si 063/2020
- Status last verified
- May 2022
- First submitted
- 6 Apr 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission
- ClinicalTrials.gov ID
- NCT04835727
- Acronym / sponsor ID
- Si 063/2020
- Keywords
- Vegetarian diet, inflammatory bowel diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Semi-vegetarian diet | Experimental | Other: Semi-vegetarian diet and increase fiber consumptionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-vegetarian diet and increase fiber consumptionAll 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 |
Primary outcome
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.
5 secondary outcomes
C-Reactive Protein (CRP)
Time frame: 1 year
fecal calprotectin level
Time frame: 1 year
Fecal microbiota
Time frame: 1 year
Quality of life score of SIBDQ
Time frame: 1 year
Quality of life score of EQ5D3L
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-vegetarian diet and increase fiber consumption in people with Inflammatory Bowel Diseases and Calprotectin, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with clinical relapses (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022; AzTrials last refreshed its copy on 26 Oct 2026.