PRACTICE CHANGER
Suggest that parents of colicky breastfed infants try probiotics (Lactobacillus reuteri), which can significantly reduce daily crying time with no adverse effects.1
STRENGTH OF RECOMMENDATION:
A: A good-quality randomized controlled trial (RCT).
Savino F, Cordisco L, Tarasco V, et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010;126:e526-e533.
ILLUSTRATIVE CASE
The parents of an otherwise healthy 10-week-old breastfed baby girl bring her in for the second time in 2 weeks because of her in-consolable crying. Physical examination and work-up remain normal, and you again diagnose colic. What can you suggest to help decrease the baby’s crying, other than the usual dietary advice?
Colic affects up to 28% of infants, causing considerable stress for parents and for their health care providers.2 Indeed, in the first 3 months of a baby’s life, crying is the No. 1 reason for pediatric visits.3 Parents often perceive—incorrectly—that the inconsolable crying is either a sign of serious illness or a result of poor parenting skills.4
A distressing problem, with few remedies
Despite the ubiquity and frustration that accompany colic, its exact etiology remains unclear and effective treatments remain elusive. With very little quality evidence to support interventions for colicky infants, we often have nothing more than grandmotherly advice to offer parents of babies with this vexing condition.
Current guidelines recommend only one strategy for breastfeeding mothers: a lowallergen diet.5 However, recent studies suggest that low counts of intestinal lactobacilli may play a role in colic and have documented improved symptoms after treatment with lactobacilli compared with treatment with simethicone.6-8 Infant formulas that contain probiotics are now available, as a result.
Although the results of the recent studies have been promising, they were not double-blinded or placebo-controlled. The study detailed here is the first to provide compelling evidence for a safe intervention for colicky breastfed infants.
STUDY SUMMARY: Lactobacilli cut crying time
In a randomized, double-blinded, placebo-controlled trial, Savino et al randomly assigned 50 exclusively breastfed colicky infants ages 2 to 16 weeks to receive either L reuteri DSM 17 938 (108 colony-forming units) or placebo daily for 21 days. Diagnosis of colic was made according to the modified Wessel’s criteria—fussy crying for ≥3 hours per day for ≥3 days per week in the week before enrollment. Their mothers were told to avoid ingesting cow’s milk during the course of the study.
Term infants adequate for gestational age were eligible for inclusion in the study. Exclusion criteria included evidence of chronic illness or gastrointestinal disorders, any intake of probiotics and/or antibiotics in the week preceding recruitment, and any formula feeding.
Parents and providers were blinded during the study, and they reported daily crying time, stool characteristics, adverse events, and growth patterns. An identical looking and tasting triglyceride oil without live bacteria was used in the placebo group. Each infant received 5 drops of L reuteri or placebo each morning 30 minutes before the morning feeding.
The primary outcome was a reduction of average crying time to <3 hours a day by Day 21. A secondary outcome was the number of infants in each group who experienced a 50% decrease in the daily average crying time from baseline on Days 7, 14, and 21 of the study.
Initially, the babies were divided equally between the control and intervention groups, but 4 participants in the control group were later excluded from analysis (1 had fever, 1 had reflux, and the parents of 2 infants did not complete the analysis).
At the time of enrollment, no significant differences were noted between the intervention and control groups regarding type of delivery, sex, age, family history of gastrointestinal disorders, growth parameters, and median daily crying time (370 minutes for the probiotics group vs 300 minutes for the placebo group).