The efficacy of the prenatal administration of Lactobacillus reuteri LR92 DSM 26866 on the prevention of infantile colic: a randomized control trial.

Infantile colic is a functional gastrointestinal disease of the infancy that its cause has not yet been properly identified. It leads to severe discomfort in the infants and anxiety in their mothers. Probiotics have recently been recommended as an effective treatment for the improvement of infantile colic. The objective of this study is to determine the role of prenatal administration of Lactobacillus reuteri (L. reuteri) LR92 DSM 26866 on the occurrence of infantile colic. This double-blinded, placebo-controlled, randomized trial was conducted with healthy pregnant women from December 2017 to December 2018 in Isfahan, Iran. A total of 145 patients was included in this study. The case group consisted of 87 pregnant women, who received daily doses of 1 × 108 colony-forming units of live L. reuteri LR92 DSM 26866, and the control group with 88 pregnant women received the placebo (containing 9% glucose solutions) for the last 4 weeks of pregnancy. Mothers and their infants in both groups did not have significant differences in anthropometric indices, and the infants' feeding pattern. Infants born to both groups of mothers followed for 5 months on signs and symptoms of colic with the repetitive examination by a blinded pediatrics assistant to record the occurrence of colic and its grading. Mothers who received placebo were 2.36 times more likely to have infants exhibiting infantile colic than mothers in the L. reuteri LR92 DSM 26866 group (CI 95%, 1.18-4.73). Using Mann-Whitney U test, the Mean (SD) of colic severity was significantly lower in the intervention group (p = 0.01). The frequency of colic and its higher grades were significantly lower in the intervention group (p = 0.03 for the presence of colic and p = 0.01 for high grades of colic). The frequency of colic presence and its different grades according to mothers' delivery mode and infant feeding patterns were not different between the two groups (p > 0.05).
Conclusion: Maternal prenatal supplementation with probiotic L. reuteri LR92 DSM 26866 during the last 4 weeks of pregnancy can prevent the occurrence and reduce the severity of infantile colic. What is Known • Lactobacillus reuteri LR92 DSM 26866 is effective in improving the symptoms of infantile colic. What is New • Prenatal administration of Lactobacillus Reuteri LR92 DSM 26866 can prevent the occurrence of infantile colic or reduce its severity.

RCT Entities:   Population Interventions Outcomes