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Probiotics to Prevent or Treat Excessive Infant Crying:  Systematic Review and Meta-analysis

Valerie Sung, MPH1,2,3; Sarsha Collett, MPH4; Tanyth de Gooyer, PhD4; Harriet Hiscock, MD1,2,3; Mimi Tang, PhD1,2,5; Melissa Wake, MD1,2,3
[+] Author Affiliations
1Department of Paediatrics, The University of Melbourne, Parkville, Australia
2Murdoch Childrens Research Institute, Parkville, Australia
3Centre for Community Child Health, Royal Children’s Hospital, Parkville, Australia
4Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia
5Department of Allergy and Immunology, Royal Children’s Hospital, Parkville, Australia
JAMA Pediatr. 2013;167(12):1150-1157. doi:10.1001/jamapediatrics.2013.2572.
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Importance  Excessive infant crying is common, distressing, but without proven effective prevention or management options. Probiotics may be a promising solution.

Objective  To examine whether probiotics are effective in the prevention/management of crying (“colic”) in infants 3 months or younger.

Data Sources  A systematic search of MEDLINE, EMBASE, and the Cochrane Library, supplemented by the metaRegister of Controlled Trials.

Study Selection  Studies that randomized infants 3 months or younger to oral probiotics vs placebo or no or standard treatment with the outcome of infant crying, measured as the duration or number of episodes of infant crying/distress or diagnosis of “infant colic.” Twelve of the 1180 initially identified studies were selected.

Data Extraction and Synthesis  This review/meta-analysis was conducted according to guidelines from the Cochrane Handbook for Systematic Reviews of Interventions, with reporting following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Data were independently extracted by 3 of us.

Main Outcome(s) and Measure(s)  Infant crying, measured as the duration or number of episodes of infant crying/distress, or diagnosis of “infant colic.”

Results  Of the 12 trials (1825 infants) reviewed, 6 suggested probiotics reduced crying, and 6 did not. Three of the 5 management trials concluded probiotics effectively treat colic in breastfed babies; 1 suggested possible effectiveness in formula-fed babies with colic, and 1 suggested ineffectiveness in breastfed babies with colic. Meta-analysis of 3 small trials of breastfed infants with colic found that Lactobacillus reuteri markedly reduced crying time at 21 days (median difference, −65 minutes/d; 95% CI, −86 to −44). However, all trials had potential biases. Meanwhile, of 7 prevention trials, 2 suggested possible benefits. Considerable variability in the study populations, study type, delivery mode/dose of probiotic supplementation, and outcomes precluded meta-analysis.

Conclusions and Relevance  Although L reuteri may be effective as treatment for crying in exclusively breastfed infants with colic, there is still insufficient evidence to support probiotic use to manage colic, especially in formula-fed infants, or to prevent infant crying. Results from larger rigorously designed studies applicable to all crying infants will help draw more definitive conclusions.

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Figure 1.
Meta-analyses of Treatment Trials Using a Random-Effects Model

A, Meta-analysis of treatment trials using median difference as the primary outcome, with a random-effects model. B, Meta-analysis of treatment trials using mean difference as the primary outcome, with a random-effects model. IV indicates inverse variance.

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Figure 2.
Meta-analyses of Treatment Trials Using a Fixed-Effects Model

A, Meta-analysis of treatment trials using median difference as the primary outcome, with a fixed-effects model. B, Meta-analysis of treatment trials using mean difference as the primary outcome, with a fixed-effects model. IV indicates inverse variance.

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