Impact of individualized solid food based diet on disease activity and gut microbiome in patients with active Crohn’s Disease
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the efficacy of solid food based diet in inducing remission in patients with active Crohn’s disease.
研究概览
简要总结
Inflammatory Bowel Disease is a chronic immune mediated disorder characterized by relapsing and remitting course. The etiopathogenesis of IBD is complex and involves genetic, environmental, microbial and immunological factors working in tandem. Diet is the fundamental environmental factor implicated in the pathogenesis of IBD as it is intricately involved in maintaining homeostasis of the gut, preserving the gut barrier and mucosal permeability and regulating the physiological secretion of hormones in the gastrointestinal tract. Diet is also an important determinant of gut microbial composition and host immune responses. Historically, supplementation of nutrition has been an adÂjunctive therapy for management of IBD. More recently howÂever, nutrition has been evaluated as a primary therapeutic option for management of IBD in the form of solid food based diet or exclusive or parÂtial enteral nutrition. Studies on use of EEN in both pediatric and adult CD have shown encouraging results. The effects of an individualized food-based diet (CD-TREAT), with similar composition to EEN, on the gut microbiome, inflammation, and clinical response were evaluated by Svolos and colleagues. They demonstrated that solid food based diet was equivalent to EEN in decreasing gut inflammation, tolerance and efficacy in patients with active CD. The current study aims to develop a nutritional therapy program for patients with Crohn’s disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with active Crohn’s Disease Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.
排除标准
- •Use of antibiotics currently or during the past 1 month Pregnancy Known HIV positive.
- •Disseminated or advanced malignancy.
- •Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up.
- •Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements.
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of study.
- •Inability to provide informed consent.
结局指标
主要结局
To study the efficacy of solid food based diet in inducing remission in patients with active Crohn’s disease.
时间窗: Week 12, Week 24
次要结局
- •To compare the efficacy of solid food based diet in inducing remission with standard pharmacotherapy and exclusive enteral nutrition(Week 12, Week 24)
