By Day 21, the number of infants with crying times >3 hours was significantly lower in the treatment group compared with the placebo group (4 vs 12, respectively; P=.009). At all stages in the study, crying time for those in the treatment group was less than in the placebo group; median crying times for the intervention group were 95, 60, and 35 minutes per day, vs 185, 150, and 90 minutes for the controls, at 7, 14, and 21 days, respectively.
The number of infants with a 50% reduction in crying time was significantly greater in the treatment group than in the placebo group on Days 7, 14, and 21 (TABLE), although both groups saw an increase in the number of children whose average crying time had dropped by 50% as time went by. The number needed to treat to reduce crying time by 50% on Day 21 was 4.
There were no differences between the groups in growth, weight gain, frequency of stools, or incidence of regurgitation or constipation. No adverse events related to the treatment were reported.
TABLE
Babies respond* to probiotics
| Day of study | L reuteri n=25 (%) | Placebo n=21 (%) | P value |
|---|---|---|---|
| 7 | 20 (80) | 8 (36) | .006 |
| 14 | 24 (96) | 13 (62) | .007 |
| 21 | 24 (96) | 15 (71) | .036 |
| *An infant with a decrease in daily average crying time of 50% from baseline was defined as a responder. | |||
WHAT’S NEW: We have an evidence-based remedy that’s safe and effective
This study represents the first randomized, double-blinded, placebo-controlled investigation of probiotics to reduce infant colic. The researchers’ focus on patient-oriented outcomes and their solid study design move the notion of probiotics’ efficacy from conjecture to evidence. Furthermore, the study documents the safety of the intervention in the treatment group. This study increases our evidence-based armamentarium for treating colic, and family physicians should consider prescribing probiotics for healthy breastfed infants with colic.
CAVEATS: Will it work for bottle-fed infants?
This study was conducted in exclusively breast-fed, healthy infants whose mothers avoided dietary cow’s milk, which limits its applicability to a more general infant population. The study was funded by the makers of the probiotic, but the rigorous study design with random allocation, double-blind design, and intention-to-treat analysis makes bias unlikely. Although no adverse effects were reported during this study, there is little available evidence about the long-term effects of probiotics in infants. As L reuteri are naturally occurring gut bacteria, however, it seems unlikely that it would be harmful in the long term.
CHALLENGES TO IMPLEMENTATION: Parents will need to purchase the probiotics
As with any non–FDA-regulated product, it will be important to guide patients toward reputable manufacturers to ensure homogeneity of dosing. A 29-day supply of BioGaia probiotic drops (100 million units once a day), which costs $37 according to the manufacturer’s Web site, http://www.biogaia.com/consumer/biogaia-probiotic-products/probiotic-drops, should be affordable for most parents. Otherwise, little stands in the way of using this therapy to reduce the crying and subsequent stress associated with infant colic.
Acknowledgement
The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.