A controlled, randomized, double-blind trial to evaluate the effect of a supplement of cocoa husk that is rich in dietary fiber on colonic transit in constipated pediatric patients.

OBJECTIVE: Although a diet that is rich in fiber is widely recommended for preventing and treating constipation, the efficacy of fiber supplements have not been tested sufficiently in children. Our aim with this pilot study was to evaluate if fiber supplementation is beneficial for the treatment of children with idiopathic chronic constipation.
METHODS: Using a parallel, randomized, double-blind, controlled trial, we conducted an interventional study to evaluate the efficacy of a supplement of cocoa husk rich in dietary fiber on intestinal transit time and other indices of constipation in children with constipation. After screening, the patients were randomly allocated to receive, for a period of 4 weeks, either a cocoa husk supplement or placebo plus standardized toilet training procedures. Before and after 4 weeks of treatment, we (1) performed anthropometry, a physical examination, and routine laboratory measurements, (2) determined total and segmental colonic transit time, (3) evaluated bowel movement habits and stool consistency using a diary, and (4) received a subjective evaluation from the parents regarding the efficacy of the treatment. The main variable for verifying the efficacy of the treatment was the total colonic transit time.
RESULTS: Fifty-six chronically constipated children were randomly assigned into the study, but only 48 children completed it. These children, who were aged between 3 and 10 years, had a diagnosis of chronic idiopathic constipation. With respect to total, partial colon, and rectum transit time, there seemed to be a trend, although statistically nonsignificant, toward faster transit times in the cocoa husk group than in the placebo group. When we analyzed the evolution of the intestinal transit time throughout the study of children whose total basal intestinal transit time was > 50th percentile, significant differences were observed between the groups. The total transit time decreased by 45.4 +/- 38.4 hours in the cocoa husk group and by 8.7 +/- 28.9 hours in the placebo group (-38.1 hours). In the case of the right colon, changes in transit time also were significant between groups. Mean changes tended toward faster transit times in the left colon and the rectum, although the differences were not statistically significant. The children who received cocoa husk supplements tended to increase the number of bowel movements by more than that of the children of the placebo group. We also observed a reduction in the percentage of patients who reported hard stools (hard scybalous or pebble-like stools), although this reduction was significantly greater in the cocoa husk group. At the end of the intervention, 41.7% and 75.0% of the patients who received cocoa husk supplementation or placebo, respectively, reported having hard stools. Moreover, a significantly higher number of children (or their parents) reported a subjective improvement in stool consistency. No significant adverse effects were reported during the study.
CONCLUSIONS: This study confirms the beneficial effect of a supplement of cocoa husk that is rich in dietary fiber on chronic idiopathic constipation in children. These benefits seem to be more evident in pediatric constipated patients with slow colonic transit time.

RCT Entities:   Population Interventions Outcomes