Dr Valerie Sung and colleagues from Australia determined whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
The research team performed a double blind, placebo controlled randomized trial.
The team evaluated 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing.
The team randomized 85 to receive probiotic, and 82 to receive placebo.
|At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group|
|British Medical Journal|
Interventions included oral daily Lactobacillus reuteri versus placebo for 1 month.
The team's primary outcome was daily duration of cry or fuss at 1 month.
Secondary outcomes were duration of cry or fuss, number of cry or fuss episodes, sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months, maternal mental health, family functioning, parent quality adjusted life years at 1 and 6 months, infant functioning at 6 months, infant fecal microbiota, and calprotectin levels at 1 month.
In intention to treat analyses the 2 groups were compared using regression models adjusted for potential confounders.
The team reported that of 167 infants randomized from 2011 to 2012, 76% were retained to primary outcome.
Of these, a subset was analyzed for fecal microbial diversity, E coli colonization, and calprotetectin levels.
The team observed that adherence was high.
Mean daily cry or fuss time fell steadily in both groups.
The team found that at 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group.
This mainly reflected more fussing, especially for formula fed infants.
The researchers found that groups were similar on all secondary outcomes.
No study related adverse events occurred.
Dr Sung and colleagues conclude, "Lactobacillus reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic."
"These findings differ from previous smaller trials of selected populations, and do not support a general recommendation for the use of probiotics to treat colic in infants."