Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 15
- 主要终点
- Changes in inflammatory response
研究概览
简要总结
The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.
详细描述
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
- •Age >= 1 year.
- •Stable patients
- •No antibiotherapy in the last 30 days
- •Inform consent signed (parent/legal representative)
排除标准
- •Patients with allergy / intolerance to cow's milk proteins
- •Metabolically unstable patient
- •Patients with metabolic intolerance to carbohydrates
- •Patients with severe disease in the last 30 days
研究组 & 干预措施
Vitafos Junior
Symbiotic Formula with DHA and antioxidants
干预措施: Symbiotic Formula with DHA and antioxidants (Dietary Supplement)
Standard Formula
Standard isocaloric and isonitrogenous formula.
干预措施: Standard Formula (Dietary Supplement)
结局指标
主要结局
Changes in inflammatory response
时间窗: At 3rd and 6th months
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
次要结局
- Changes in Interleukin levels(At 6th month)
- Changes in nutritional status(At 3rd and 6th months)
- Changes in microbiota profile(At 3rd and 6th months)
- Incidence of Infections(At 1st, 3rd and 6th months)