Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Time to resolution of GI symptoms
研究概览
简要总结
Micronutrients missing in the diet may assist in supporting digestive health in children with chronic GI issues. This study will monitor changes in symptoms associated with digestive problems in children provided with a dietary supplement that will be taken in conjunction with the standard of care.
详细描述
Children with GI symptoms have varying response to the standard of care treatments. A dietary supplement of polyphenols from green tea and pomegranate extracts provides micronutrients often missing from conventional American diets. The objective of this study is to monitor changes in GI symptoms when the supplement is provided alongside the standard of care for children with symptoms that have been present for more than two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-patients with diagnosis of unresolved gastrointestinal distress
- •Parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days
- •Parent or guardian willing to record changes in GI symptoms on a questionnaire
- •Parent or guardian willing to bring the child for a clinic visit to close-out participation in the study
排除标准
- •requires care in an ICU
- •has documented intestinal stricture, stenosis, obstruction, or abscess
- •has concomitant congenital diseases
- •are immunodeficient
- •has malformation of the GI tract
- •is unable to swallow fluids
- •parent or guardian is unable or unwilling to provide informed consent
结局指标
主要结局
Time to resolution of GI symptoms
时间窗: 3 weeks
次要结局
未报告次要终点