GOS Prebiotic Effect in Children Constipation

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil

Criteria

Inclusion Criteria:

• Functional constipation defined by Rome III criteria

• Consent form signed by parent or guardian

Exclusion Criteria:

• Patients with systemic, genetic or neurological diseases.

• Lactose intolerance

• Laxative use

• Probiotic use

• Antibiotic use during the study