Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of participants with clinical relapses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Semi-vegetarian diet and increase fiber consumption (Other)
结局指标
主要结局
Rate of participants with clinical relapses
时间窗: 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.
次要结局
- fecal calprotectin level(1 year)
- Fecal microbiota(1 year)
- Quality of life score of SIBDQ(1 year)
- Quality of life score of EQ5D3L(1 year)
- C-Reactive Protein (CRP)(1 year)
研究者
Julajak Limsrivilai
Assistant Professor
Mahidol University