Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial

Abstract

Objective: To assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of functional constipation in children.

Study design: A randomized, double-blind, placebo-controlled trial was conducted in 94 children aged <5 years with functional constipation according to the Rome III criteria. Children were assigned to receive Lcr35 (8 × 10⁸ colony-forming units, n = 48) or placebo (n = 46), twice daily, for 4 weeks. The primary outcome measure was treatment success, defined as 3 or more spontaneous stools per week, without episodes of fecal soiling, in the last week of the intervention. Analyses were by intention to treat.

Results: Eighty-one (86%) children completed the study. There was no significant difference in treatment success between the placebo and the Lcr35 group (28/40 vs 24/41, respectively; relative risk, 0.6, 95% CI 0.24-1.5, P = .4). There was a significant increase in the frequency of defecation from baseline to week 4 in both the placebo group (median [IQR] 2.0 [1.0, 2.0] to 6.0 [4.0, 9.0], P < .001) and in the Lcr35 group (2.0 [1.0, 2.0] to 4.0 [3.0, 5.0], P < .001), but the defecation frequency in the placebo group was significantly greater than that in the Lcr35 group at weeks 1, 2, 3, and 4.

Conclusion: Lcr35 as a sole treatment was not more effective than placebo in the management of functional constipation in children <5 years. This study adds to current recommendations that do not support the use of probiotics in the treatment of childhood constipation.

Trial registration: ClinicalTrials.gov: NCT01985867.

Keywords: gastrointestinal disorders; pediatrics; probiotics.