Faculty of Medicine, Chulalongkorn University
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The frequency of stool
研究概览
简要总结
This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.
详细描述
Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B.
Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D.
Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner.
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)
盲法说明
The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children will be enrolled in this study when they meet 2 criteria:
- •Age from 6 months to 18 years old
- •Children are diagnosed with FC according to ROME IV criteria
排除标准
- •Children will be excluded from the study if they meet any of the following criteria:
- •Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc.
- •Suspected GI obstruction
- •Receiving medication affecting bowel movement
- •Having a history of allergy to PEG and stevia.
研究组 & 干预措施
PEG-Chula
PEG-Chula is developed from local PEG 4000 used at King Chulalongkorn Memorial Hospital (KCMH) with the addition of sweetener and flavours and prepared into sachets labelled A, B, C and D.
干预措施: Local PEG4000 (Drug)
Standard PEG
Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance.
干预措施: Commercial PEG4000 (Drug)
结局指标
主要结局
The frequency of stool
时间窗: At 7 days, 14 days, 28 days and 56 days
The frequency of stool per day
Stool consistency assessed by Bristol stool chart
时间窗: At 7 days, 14 days, 28 days and 56 days
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool
次要结局
- Fecal incontinence(At 7 days, 14 days, 28 days and 56 days)
- Adverse events(At 7 days, 14 days, 28 days and 56 days)
- Palatability of medication assessed by facial Hedonic scale(At 7 days, 14 days, 28 days and 56 days)
- Rectal diameter(At 7 days, 14 days, 28 days and 56 days)
研究者
Duc Long Tran
Principal investigator of Center of Excellence in Clinical Virology, Faculty of Medicine
Chulalongkorn University