Patient-Oriented Evidence That Matters

A Specific Probiotic Decreases Crying in Infants Younger than Two Months with Colic


Am Fam Physician. 2020 Nov 15;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

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This series is coordinated by Sumi Sexton, MD, editor-in-chief.

A collection of POEMs published in AFP is available at https://www.aafp.org/afp/poems.



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