The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Efficacy of Modulen Diet
研究概览
简要总结
The aim of this study is to evaluate prospectively a possible effect of an oral polymeric diet enriched with TGF-beta 2 (Modulen) as compared to Budesonide (one of the commonly accepted treatments for Crohn's disease) on clinical response, mucosal healing and intestinal microbiota in adult patients with newly diagnosed Crohn's disease using a capsule endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Crohn's Disease
- •Mild to moderate severity
排除标准
- •Patients who received systemic steroid or Budesonide or biological treatment
- •Recent bowel surgery
- •Colostomy, ileostomy
- •Short bowel syndrome
- •Obstructive symptoms
- •Pregnancy, lactation
- •Cardiac pacemaker or defibrillator
- •Swallowing problems
- •Uncontrolled metabolic diseases or any other condition that can be exacerbated by steroids
研究组 & 干预措施
Modulen Diet
Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
干预措施: Modulen (Dietary Supplement)
Budesonide Treatment
Crohn patients will be given Budesonide treatment
干预措施: Budesonide (Drug)
结局指标
主要结局
Efficacy of Modulen Diet
时间窗: 8 weeks
Patients will undergo capsular endoscopy before and after dietary intervention and mucosal healing will be accessed using standard Lewis Score. Outcome will be compared to efficacy of Budesonide treatment.
次要结局
未报告次要终点