Probiotics and crying time in babies with infantile colic
| Author, date and country | Patient group | Study type | Outcomes | Key results | Study weaknesses |
|---|---|---|---|---|---|
| Anabrees et al, 2013,1 Saudi Arabia | 220 breastfed infants enrolled into 3 selected studies were given Lactobacillus reuteri or control (placebo or simethicone) | Meta-analysis of randomised trials | Crying times at 21 days after starting treatment Treatment success | Mean difference −56.03 min; 95% CI (−59.92 to −52.15) RR of 0.06; (95% CI 0.01 to 0.25) NNT 2 | Breast fed infants only. 1 study included was assessed as poor quality |
| Calderon et al, 2014,2 Spain | 17 ‘healthy infants’. Age of infants and duration of monitoring unclear. Symptoms associated with colic monitored using questionnaires and two physical visits. All children prescribed L. reuteri | Observational prospective study | Crying and infant discomfort | Reduced during the study | No control group. Very small pilot study. The study's external validity is limited |
| Indrio et al, 2014,3 Italy | 468 term newborns (age <1 week) randomly allocated L. reuteri or placebo for 90 days | Prospective, multicentre, double-blind, placebo controlled RCT | Duration of inconsolable crying at 90 days | 38 min in probiotic group vs 71 min in placebo group (p<0.01) | Study recruited unselected general population of neonates. CIs not available in study |
| Sung et al, 2014,4 Australia | 167 breastfed or formula-fed infants aged <3 months (Wessel’s criteria for colic) assigned to receive probiotic or placebo | Phase 3 double blind, randomised placebo controlled trial | Daily duration of crying or fussing at 1 month | Probiotic group cried or fussed for 49 min more than placebo group (95% CI 8 to 90 min, p=0.02) | Reduced dose of L reuteri compared to other studies. Majority of infants selected were from emergency or urgent care setting |
| Chau et al, 2015,5 Canada | 52 infants with colic that met modified Wessel’s criteria. Randomised to either receive L. reuteri (24) or placebo (28) for 21 days. Maternal questionnaire- daily crying and fussing times | Randomised, double blind, placebo-controlled trial | Reduced total average crying and fussing times and daily crying times Number with 50% reduction in crying time | Median 60 min per day vs 102 min per day (p=0.045) 17 vs 6, p=0.035; relative risk, 3.3; CI (1.55 to 7.03) | Infants up to 6 months of age. Does not reflect age of incidence of colic. Large inter-quartile range of crying time may not reflect clinical significance |