Objectives: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
*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.
Address correspondence and reprint requests to Mauro S. Toporovski, PhD, Department of Pediatrics, School of Medicine, Santa Casa de São Paulo, Avenida Pacaembú, 1083, CEP-01234-001 São Paulo, Brazil (e-mail: email@example.com).
Received 8 August, 2013
Accepted 17 October, 2013
www.clinicaltrials.gov registration number: 01333787.
This research was supported by the National Counsel of Technological and Scientific Development (CNPq).
The authors report no conflicts of interest.