drugset / Trial / NCT02183766

GOS Prebiotic Effect in Children Constipation

NCT02183766

Phase 1 Completed 20 enrolled University of Campinas, Brazil
Non-randomizedCrossoverDouble-blindTreatment

Summary

Some prebiotics are useful for improving symptoms related to constipation, but clinical trials including infants and older children are scarce. A double-blind, placebo-controlled, crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides (GOS) on functional constipation in children and adolescents. Twenty children aged 4 to 16 years of age, who spontaneously sought medical care at a primary healthcare unit, received 1.7g GOS or placebo (Maltodextrin) treatment for 30 days, followed by a 15-day washout period and a 30-day use of an alternative product. A clinical score was calculated at baseline, at the 15th (D15) and 30th (D30) day of each period, to assess bowel movement frequency, straining/ pain during defecation and stool consistency. Oral anal transit time with activated charcoal was determined at baseline and D30 of each period.

Timeline

Start
2010-04
Primary completion
2012-03
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Galactooligosaccharide Other / unclassified 6 ml Oral

Indications