brand logo

Am Fam Physician. 2020;102(9):online

Clinical Question

Is probiotic supplementation effective in decreasing crying in infants with colic?

Bottom Line

The treatment of breastfed infants with colic using a specific probiotic—Bifidobacterium animalis subsp. lactis—significantly decreased crying duration and episodes. The probiotic decreased the daily crying duration by at least one-half in 80% of infants (number needed to treat = 2). Other studies have not consistently shown benefit. This study is small, but it may be that the particular probiotic matters. If you recommend a probiotic to parents, suggest they check labels to find this specific one. (Level of Evidence = 1b−)


The researchers worked with community pediatricians to identify breastfed infants younger than eight weeks with reported colic for at least one week, consisting of crying or irritability without obvious cause for at least three hours a day and at least three days per week. Identified infants were followed up for one week before the intervention started to confirm the diagnosis. Then, 80 infants were randomized using concealed allocation to receive placebo or supplementation with the probiotic Bifidobacterium animalis subsp. lactis (Bifidolactis Infant) each morning by mouth for 28 days. Parents kept a diary and patients were evaluated weekly by a pediatrician. Follow-up was 100% in both groups and analysis was by intention to treat. The primary outcome, a reduction of 50% or more of average daily crying duration after 28 days of intervention, occurred in 80% of the treated infants compared with 33% of the untreated children (P < .0001) and began with the first week of treatment. The average minutes of crying per day, the number of crying episodes, and the number of daily stools were lower with treatment.

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry

Allocation: Concealed

Setting: Outpatient (primary care)

Reference: Nocerino R, De Filippis F, Cecere G, et al. The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12® in infant colic: a randomised, double blind, placebo-controlled trial. Aliment Pharmacol Ther. 2020;51(1):110–120.

Editor's Note: Dr. Shaughnessy is an assistant medical editor for AFP.

POEMs (patient-oriented evidence that matters) are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, see Copyright Wiley-Blackwell. Used with permission.

For definitions of levels of evidence used in POEMs, see

To subscribe to a free podcast of these and other POEMs that appear in AFP, search in iTunes for “POEM of the Week” or go to

This series is coordinated by Natasha J. Pyzocha, DO, contributing editor.

A collection of POEMs published in AFP is available at

Continue Reading

More in AFP

Copyright © 2020 by the American Academy of Family Physicians.

This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP.  See permissions for copyright questions and/or permission requests.