Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Malabsorption
研究概览
简要总结
This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.
详细描述
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food.
- •Willing to comply with the prescribed diet follow-up for CD.
排除标准
- •Having received antibiotics in the previous 3 months
- •Having undergone intestinal resection surgery≥70-75%
- •Refuse to participate in the study
- •Comorbidity that allows to suspect survival <1 year
结局指标
主要结局
Malabsorption
时间窗: 6 months
Body Weight Change (kg)
次要结局
- Changes in the consistency of the stools according to Bristol scale.(6 months)
- Fat malabsorption(6 months)