Functional constipation in children: A follow-up of two randomized controlled trials

Abstract

BackgroundThe goal of treatment of functional constipation (FC) is to restore a regular defecation pattern and to prevent relapses. AimTo assess long-term outcomes in children with FC. MethodsThis was a follow-up study of children previously enrolled in 2 independent randomized controlled trials. In the first trial, children randomly received glucomannan (GNN) or placebo for 4 weeks. In the second study, children received a fermented dairy product with Bifidobacterium lactis I-2494 (B. lactis) or placebo for 3 weeks. Follow-up data were collected using a standardized questionnaire. The primary outcome measure was treatment success (≥3 spontaneous bowel movements with no episodes of soiling during the last week, abdominal pain, or need for laxatives). The secondary outcomes were FC according to the Rome III criteria and the need for laxative therapy. ResultsIn the GNN study, follow-up data at 24 months were obtained from 63 of 72 (87.5%) of children. Treatment success was reported in 36/63 (57%), FC in 17/63 (27%), and the need for laxatives in 13/63 (21%). There were no differences in outcomes between groups. In the B. lactis study, follow-up data at 36 months were obtained from 57 of 82 (70%) of children. Treatment success was reported in 26/57 (46%), FC in 21/57 (37%), and the need for laxatives in 15/57 (26%). There were no differences in outcomes between groups. ConclusionA substantial portion of children remained symptomatic after 2–3 years of follow-up indicating a need for regular evaluation of children with FC.