Polyethylene Glycol for Childhood Constipation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
研究概览
简要总结
Background:
Aim:
Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children.
Study design:
Randomized, open-label trial.
Randomized, double-blind, placebo controlled trial.
详细描述
Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg.
In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 1 - 18 age
- •functional constipation according to the Rome III Criteria
- •consent of parents or guardians of the child to participate and study
排除标准
- •organic cause constipation (including surgeries within the lower GI tract)
研究组 & 干预措施
Polyethylene glycol small dose
Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
干预措施: Polyethylene glycol 4000 (Drug)
Polyethylene glycol high dose
Polyethylene glycol 4000: 0.7g/kg for 6 weeks
干预措施: Polyethylene glycol 4000 (Drug)
结局指标
主要结局
therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
时间窗: the number and consistency of the stool will be recorded at 6th week of intervention
次要结局
- the number of incontinence episodes(the number of the incontinence episodes will be recorded at the 6th week of intervention)
- the number of painful defecation(the number of painful defecation will be recorded at the 6th week of intervention)
- the number of episodes of abdominal pain(the number of the episodes of abdominal pain will be recorded at the 6th week of intervention)
- the number of stools delivered at 6th week of intervention(the number of the stools will be recorded at the 6th week of intervention)
- the number of patients needed laxatives during treatment(the number patiens needed laxatives will be recorded for six weeks of intervention)
- side effects(the number and the character of the side effects will be recorded for six weeks of intervention)
研究者
Andrea Horvath-Stolarczyk
MD PhD
Medical University of Warsaw