Glucomannan for Childhood Functional Constipation.
关键词
抽象
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.
日期
| 最后验证: | 01/31/2017 |
| 首次提交: | 05/06/2010 |
| 提交的预估入学人数: | 06/27/2010 |
| 首次发布: | 06/28/2010 |
| 上次提交的更新: | 02/21/2017 |
| 最近更新发布: | 02/23/2017 |
| 实际学习开始日期: | 03/31/2009 |
| 预计主要完成日期: | 05/31/2010 |
| 预计完成日期: | 05/31/2010 |
状况或疾病
干预/治疗
Dietary Supplement: Glucomannan
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Glucomannan glucomannan preparation in sachets: 1 saschet of 1.26g 2 times per day (daily dosage 2,52g); duration of intervention: 4 weeks | Dietary Supplement: Glucomannan 1.26 g per sachet; 2 sachets per day for 4 weeks. |
| Placebo Comparator: Placebo maltodextrin prepared in sachets (1,3 g per sachet); 2 sachets per day; duration of intervention: 4 weeks | Dietary Supplement: Placebo prepared in sachets (1.3g); 2 sachets per day for 4 weeks |
资格标准
| 有资格学习的年龄 | 3 Years 至 3 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. treatment success [1 week]
次要成果指标
1. stool frequency [1 week]
2. soiling [1 weeks]
3. hard stools or painful defecations [1 week]
4. abdominal pain [1 week]
5. need for interventional laxative [1 week]
6. flatulence [1 week]
7. adverse events [4 weeks]
