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

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.

Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine whether administration of Lactobacillus reuteri (L reuteri) DSM 17938 is beneficial in breastfed infants with infantile colic. STUDY DESIGN: Eighty infants aged <5 months with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment), who were exclusively or predominantly (>50%) breastfed were randomly assigned to receive L reuteri DSM 17938 (10(8) colony-forming units) (n = 40) or an identically appearing and tasting placebo (n = 40), both orally, in 5 drops, 1 time daily, for 21 days. The primary outcome measures were the treatment success, defined as the percentage of children achieving a reduction in the daily average crying time ≥ 50%, and the duration of crying (minutes per day) at 7, 14, 21, and 28 days after randomization. RESULTS: The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 (P = .026), at day 14 (relative risk (RR) 4.3, 95% CI 2.3-8.7), at day 21 (RR 2.7, 95% CI 1.85-4.1), and at day 28 (RR 2.5, 95% CI 1.8-3.75). In addition, throughout the study period, the median crying time was significantly reduced in the probiotic group compared with the control group. CONCLUSION: Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo.