A Randomized Controlled Trial to Evaluate Efficacy and Tolerability of Plant Based Diet in Maintaining Remission in Patients with Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 1. Clinical relapse as defined by increase in SCCAI ≥3 for more than 7 days
研究概览
简要总结
Inflammatory bowel disease (IBD) is rapidly emerging in the developing world including India. The interplay between genetic susceptibility and environmental risk factors is the most accredited theory in the etiopathogenesis of IBD. Diet is a key environmental factor. It plays a major role in the homeostasis of gut microbial composition, functioning and consequently the microbial metabolites. Dietary composition regulates mucosal barrier function, gut immunity and gut inflammation.
Because plant based diet has a positive impact on gut microbiome and is a concept which has not been previously explored in India, forms the basis of the present study. In this study, by the intervention of plant based diet we look forward for change in gut microbiome which may lead to decrease in relapse rate in ulcerative colitis.
In this research we are testing the is the efficacy of plant based diet (PBD) in preventing relapse in patients with ulcerative colitis in remission through its action on gut microbiome. PBD involves the foods only which are plant products and not from animal source (except fresh curd). PBD has been tested before in patients with ulcerative colitis, but studies have included hospitalized patients and some studies have shown it to be efficacious while some have not. The success depends upon the adherence to the diet and the disease activity of the patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 – 80 years
- •Patients with clinical remission for 3month as assessed by simple clinical colitis activity index (SCCAI 0-2)
- •Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks
- •Patients on stable doses of azathioprine/6-mercaptopurine for past 3 months
- •Last steroid intake- 6 months prior
- •Patients giving consent for plant based diet
- •Patients who agree to adhere to the diet schedule.
排除标准
- •Patients with disease activity (SCCAI ≥3)
- •Patients on steroids
- •Patients who have received topical 5-ASA or topical steroids in the past 2 weeks
- •Patients with H/O of antibiotic exposure in the past 4 weeks
- •Patients requiring hospitalization
- •Patients with H/O bowel surgery
- •Patients with concomitant GI infection
- •Pregnancy
- •Patients with other co morbid illnesses
- •Patients not giving consent for plant based diet
- •Patients who disagree to adhere to the diet schedule.
结局指标
主要结局
1. Clinical relapse as defined by increase in SCCAI ≥3 for more than 7 days
时间窗: 1. Clinical relapse as defined by increase in SCCAI ≥3 for more than 7 days | 2. Change in microbiome composition as evaluated by 16srRNA analysis
2. Change in microbiome composition as evaluated by 16srRNA analysis
时间窗: 1. Clinical relapse as defined by increase in SCCAI ≥3 for more than 7 days | 2. Change in microbiome composition as evaluated by 16srRNA analysis
次要结局
- 1. Adherence to plant based diet.(2. Quality of life at 1 year as assessed by Short Inflammatory Bowel Disease)