A Controlled, Randomized, Double-blind Trial to Evaluate the Effect of a Dietary Fiber Mixture During Maintenance Treatment and on Colonic Transit Time in Constipated Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Clinical response - Therapeutic success
研究概览
简要总结
The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the treatment of chronic constipation and on the colonic transit time in children.
详细描述
In spite of an increase in the consumption of fibers being indicated for the treatment of constipation, few clinical trails have evaluated its efficiency. In the majority of prior studies only the effect of a single type of fiber was evaluated. Each type of fiber presents a particular characteristic, which determines its action mechanism and performance in different parts of the colon. Therefore, theoretically, greater effectiveness could well be observed when different types of fibers are associated into a single product for fiber supplementation.
A randomized, parallel, double-blind, controlled was performed to evaluate the effect of a dietary fiber mixture in constipated pediatric patients.
Children aged between 4 and 12 years were included in the study and the initial diagnosis of functional chronic constipation was made in accordance with the Rome III criteria. The children having attended the Pediatric Gastroenterology Ambulatory of the Federal University of Sao Paulo and the Santa Casa de Misericórdia hospital in Sao Paulo city. All of the children were undergoing constipation maintenance treatment with the use of a laxative in a dosage less than 1.0 ml/Kg for milk of magnesia, mineral oil or lactulose or less than 0.5 g/Kg for polyethylene glycol 3350.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 4 and 12 years;
- •Maintenance treatment using low dose of laxative;
- •A family with the socio-economic culture that would make it possible to carry out the procedures of the study's protocol.
排除标准
- •Children with organic cause constipation such as Hirschsprung disease, cerebral paralysis, anorectal and spinal medulla abnormalities and metabolic illnesses;
- •The regular use of a fiber supplement during the 4 weeks prior to admission;
- •The use of medications that would cause constipation;
- •Absence of a fixed or mobile telephone in order to make contact.
结局指标
主要结局
Clinical response - Therapeutic success
时间窗: 4 weeks
The primary outcome result measurement was the therapeutic success. This therapeutic success was considered when the patient demonstrated daily evacuations or had interposing days of pasty consistency, without pain or difficulty and the absence of fecal incontinence during the 4 weeks of intervention, without the need of using a laxative or rectal enema.
次要结局
- Frequent daily evacuations, format and consistency of the feces, total and segmental transit time(4 weeks)