Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in stool consistency
研究概览
简要总结
This study examines the effects of dietary fiber in the treatment of functional childhood constipation.
详细描述
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency.
All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-16 years of age with functional constipation as defined based on the Rome III criteria
排除标准
- •Constipation attributable to organic and anatomic causes or intake of medication
- •Children who had previous surgery of the colon or anus
- •History of allergy/intolerance to components of snack bar (e.g. celiac disease)
研究组 & 干预措施
Fiber 1
Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks
干预措施: Fiber (Other)
Fiber 2
Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks
干预措施: Fiber (Other)
Placebo
Bar with low fiber content (placebo) once daily for 4 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in stool consistency
时间窗: 4 weeks
Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
Change in stool frequency
时间窗: 4 weeks
次要结局
未报告次要终点