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Abstract

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.

Trial registration: ClinicalTrials.gov NCT01046617.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus reuteriReduced Crying TimeBeneficial
Large
Lactobacillus reuteri DSM 17938Reduced Crying Time in Infants with ColicBeneficial
Large
Lactobacillus reuteri HA-188Reduced Crying TimeBeneficial
Large
Lactobacillus reuteri NCIMB 30242Reduced Crying DurationBeneficial
Large
Lactobacillus reuteri OsfortisReduced Crying in InfantsBeneficial
Large
Lactobacillus reuteri RC-14Increased Treatment Success for Infant ColicBeneficial
Large
Lactobacillus reuteri RC-14Reduced Crying in InfantsBeneficial
Large
Lactobacillus reuteri SD-5865Reduced Crying DurationBeneficial
Large
Lactobacillus reuteri UALg-05Improved Treatment Response RateBeneficial
Large
Lactobacillus reuteri UALg-05Reduced Crying Time in Infants with ColicBeneficial
Large
Lactobacillus reuteri UALre-16Reduced Crying Time in Infants with ColicBeneficial
Large
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