Glucomannan for Childhood Functional Constipation.
الكلمات الدالة
نبذة مختصرة
وصف
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.
تواريخ
| آخر التحقق: | 01/31/2017 |
| تم الإرسال لأول مرة: | 05/06/2010 |
| تم إرسال التسجيل المقدر: | 06/27/2010 |
| أول نشر: | 06/28/2010 |
| تم إرسال آخر تحديث: | 02/21/2017 |
| آخر تحديث تم نشره: | 02/23/2017 |
| تاريخ بدء الدراسة الفعلي: | 03/31/2009 |
| تاريخ الإنجاز الأساسي المقدر: | 05/31/2010 |
| التاريخ المتوقع لانتهاء الدراسة: | 05/31/2010 |
حالة أو مرض
التدخل / العلاج
Dietary Supplement: Glucomannan
Dietary Supplement: Placebo
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| 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 |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 3 Years إلى 3 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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 |
النتيجة
مقاييس النتائج الأولية
1. treatment success [1 week]
مقاييس النتائج الثانوية
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]
