Glucomannan in Treating Childhood Functional Constipation: a Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- treatment success
研究概览
简要总结
The purpose of this study is to determine whether administration of glucomannan (dietary fiber) is effective in treating functional constipation in children.
详细描述
Constipation is a common condition in children. In many patients symptoms persist to adulthood and decrease quality of life. The standard treatment, mostly osmotic laxatives such as lactulose or polyethyleneglycols, are often ineffective and may cause adverse events. Therefore, alternative treatment measures are being searched for.
Glucomannan, a water-soluble fiber polysaccharide from the tubers of the Japanese Konjac plant, has been reported to be effective in constipated children. To date, 2 randomized trials were performed.1,2 One evaluated the effect as glucomannan as an adjunct to standard treatment.1 Another was conducted in neurologically impaired children, who constitute a specific population that cannot be compared to patients with functional constipation.2 In both trials, the number of patients was relatively small.
Well-powered, randomized controlled study is required to evaluate clinical effectiveness of glucomannan as a sole treatment in childhood functional constipation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants and researchers conducting the study were blinded. Intervention products were prepared in sachets centrally by the hospital pharmacy by a person not involved in the conduct of the trial. The active product and placebo were packaged in identical sachets and labeled with one of two codes, each allocated to the experimental product or placebo. This procedure was performed by an independent pharmacist, who was the only person aware of the codes' meaning. The appearance and texture of the dry products were identical.
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •functional constipation diagnosed according to Rome Criteria III (duration of symptoms for at least 2 months prior to study inclusion)
- •age 3 to 16 years
- •informed consent from parents and/or child
排除标准
- •organic cause of defecation disorders (Hirschsprung's disease, spinal anomalies or anorectal pathology; history of gastro-intestinal surgery)
- •mental retardation
- •metabolic disease (e.g. hypothyroidism)
- •irritable bowel syndrome
- •intake of medications influencing gastrointestinal motility
研究组 & 干预措施
Placebo
maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks
干预措施: maltodextrin (Dietary Supplement)
Glucomannan
glucomannan preparation in sachets: 1 saschet of 1.26g 2 times per day (daily dosage 2,52g); duration of intervention: 4 weeks
干预措施: Glucomannan (Dietary Supplement)
结局指标
主要结局
treatment success
时间窗: 1 week
paasing at least 3 stools per week with no episodes of soiling
次要结局
- stool frequency(1 week)
- hard stools or painful defecations(1 week)
- flatulence(1 week)
- soiling(1 weeks)
- abdominal pain(1 week)
- need for interventional laxative(1 week)
- adverse events(4 weeks)