*Division of Pediatric Gastroenterology, Federal University of São Paulo, São Paulo, Brazil †Department of Pediatrics, School of Medicine, Santa Casa de São Paulo, São Paulo, Brazil.
J Pediatr Gastroenterol Nutr. 2014 Mar;58(3):297-302. doi: 10.1097/MPG.0000000000000224.
The aim of the study was to test the clinical efficacy and effect on colonic transit time (CTT) of a dietary fiber mixture given to children with controlled chronic constipation (CC) after the withdrawal of stool softeners and enemas.
This randomized, placebo-controlled, double-blind clinical trial involved 54 patients aged 4 to 12 years and had CC that was controlled by the use of low-dose stool softeners. The use of these softeners was discontinued when the patients were admitted to the clinical trial. The patients were randomized into 2 groups for the 4-week study period. One group received a dietary fiber mixture and the other group received a placebo (maltodextrin). The primary outcome was therapeutic failure (oral stool softeners or enemas was required to prescribe during the trial). Secondary outcomes included defecation frequency, stool consistency (measured using the Bristol Stool Form Scale), and CTT.
Therapeutic failure was observed in 34.6% (9/26) of the patients in the dietary fiber mixture group and in 35.7% (10/28) in the control group (P = 0.933). The mean increase in daily bowel movements was 0.53 in the dietary fiber mixture group and 0.23 in the control group (P = 0.014). The patients in the dietary fiber mixture group (60.0%) passed nonhardened stools more frequently than did those in the control group (16.7%, P = 0.003). The CTT was similar for both groups.
The fiber mixture did not prevent the suspension of stool softeners or lead to reduced CTT; however, the mixture promoted an increased frequency of defecation and an improvement in the stool consistency.
本研究旨在测试膳食纤维混合物在停用通便剂和灌肠后对慢性功能性便秘（CC）儿童的临床疗效和结肠传输时间（CTT）的影响。
这是一项随机、安慰剂对照、双盲临床试验，共纳入 54 名 4 至 12 岁的慢性便秘患儿，这些患儿通过低剂量通便剂得到控制。当患儿入组临床试验时，停止使用这些通便剂。患者随机分为两组，进行为期 4 周的研究。一组接受膳食纤维混合物，另一组接受安慰剂（麦芽糊精）。主要终点是治疗失败（试验期间需要口服通便剂或灌肠）。次要结局包括排便频率、粪便稠度（采用布里斯托粪便形状量表测量）和 CTT。
膳食纤维组有 34.6%（9/26）的患者和对照组有 35.7%（10/28）的患者治疗失败（P=0.933）。膳食纤维组每日排便次数平均增加 0.53 次，对照组增加 0.23 次（P=0.014）。膳食纤维组（60.0%）更频繁地排出非硬便，而对照组为 16.7%（P=0.003）。两组 CTT 相似。
纤维混合物不能预防通便剂的停用或导致 CTT 降低；然而，混合物促进了排便频率的增加和粪便稠度的改善。
