Effectiveness of Probiotics in the Management of Functional Constipation in Children: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

A randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy of probiotics (L. acidophilus, B. longum, and S. thermophylus 2 × 109 cfu/day) in 78 children aged 4–10 years old with functional constipation (Rome III criteria) at several schools in Jakarta, Indonesia. The case finding used a validated parent-report questionnaire. Subjects were randomly assigned to receive either oral probiotics (L. acidophilus, B. longum, and S. thermophylus 1 × 109 cfu/day) or placebo twice a day for 4 weeks. There were more subjects in the probiotics group who had improvement in stool consistency (P = 0.022) and difficulty/painful defecation (P = 0.009) than in the placebo group. Other symptoms (frequency of bowel movements, withholding behavior, fecal incontinence, and presence of stool mass in abdomen) also improved, but no statistically significant differences were found. Constipation severity significantly improved in the probiotics group (P = 0.026). Overall improvement (defined as decrease of constipation severity score >60% at the end of evaluation) was higher in the probiotics group than the placebo group (31/39 versus 18/39, P = 0.002) with number needed to treat (NNT) of 3 (95%CI 2;8). The present study shows that probiotics (L. acidophilus, B. longum, and S. thermophylus 2 × 109 cfu/day) are effective in the management of functional constipation in children.