The study notes that the pathogenesis of infant colic is poorly understood, but that a growing body of evidence suggests that alterations of gut microbiota can contribute to the development of this condition: Subjects with IC have a lower diversity and stability of the gut microbiota during the first two weeks of life.
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The trial looked at 72 otherwise healthy exclusively breastfed infants aged seven weeks or younger, with signs and symptoms of IC. Infants were randomized to either Group 1, parental reassurance and education plus BB-12, or Group 2, parental reassurance and education plus placebo. Infants were given six drops of the assigned study product once a day for 28 days. Parents were instructed to complete a diary daily with data concerning administration of the product, number and duration of crying episodes, number of bowel movements, consistency of baby’s stool, sleep duration, and possible adverse events.The results: Babies given BB-12 saw a significantly higher reduction in crying duration compared to the placebo group, as well as a reduction in crying episodes. The researchers wrote: “Administration of BB-12… had beneficial effects on sleep duration and on stool frequency and consistency. The results are well in line with data of a previous open-labelled trial reporting that BB-12 decreased the duration of crying time in infants with colic.” The researchers do, however, note the relatively small number of observations and the exclusion of formula-fed infants.
