Probiotic Reduces Crying Time in Colicky Infants

Diana Swift

December 04, 2019

The annals of sleep-deprived parenthood abound with tales of incessantly crying colicky babies. But evidence is mounting that probiotics can give babies relief from colic, a functional gastrointestinal disorder believed to be tied to disturbances in the gut microbiota.

Although the pathogenesis of colic is unclear, a new study reports that the probiotic Bifidobacterium animalis subspecies lactis BB-12 (Bifidolactis Infant, Sofar) effectively eases infant colic. In a randomized, double-blind, placebo-controlled trial, Rita Nocerino, CPN, of the Department of Translational Medical Science at the University of Naples Federico II, in Italy, and colleagues found that treatment with BB-12 for 28 days was associated with a greater rate of reduced daily average crying time (≥50%) compared with placebo.

The effect on crying time emerged as early as the first week of BB-12 supplementation. The probiotic also appeared to have beneficial effects on sleep duration as well as stool frequency and consistency.

The trial results were published online online December 4 in Alimentary Pharmacology and Therapeutics.

The researchers randomly assigned 80 healthy but colicky infants no older than 7 weeks who were exclusively breastfed to receive placebo or a daily dose of BB-12 1 x 109 colony-forming units. The mean age of the babies was a little more than 1 month, and more than 50% were boys.

The mean daily duration of crying bouts was consistently shorter in the BB-12 group at each week and decreased from week to week. Mean change from baseline in the intention-to-treat population was significantly greater in the BB-12 group than the placebo group: –129.9 ± 43.7 and –84.3 ± 51.4, respectively (P = .0001).

In the per-protocol analysis, 80% of BB-12 recipients showed a ≥50% reduction in crying duration after 28 days, compared with 31.5% of those in the placebo group (P < .0001).

The mean number of daily crying episodes was lower in the BB-12 group at each study week. The mean change from baseline to the last week was –4.7 ± 3.4 in the intervention group vs –2.3 ± 2.2 in the placebo group (P = .001).

Infants' sleeping time in both groups increased from baseline, with a mean change at the last week of 36.5 ± 98.8 minutes per day in the BB-12 group (range, –225.7 to 345.0 minutes) and 47.9 ± 108.6 minutes per day (range, –265.0 to 225.0 minutes) in the placebo group.

BB-12 recipients showed an increase in anti-inflammatory biomarkers in stool, including an abundance of Bifidobacterium as well as an increase in levels of butyrate, HBD-2, LL-37 and sIg, which are associated with a decrease in levels of the inflammatory marker calprotectin. That finding suggests that this probiotic strain has an immunomodulatory action in the infant gut; its beneficial effect could stem from both immune and nonimmune mechanisms that modulate the structure and function of the microbiota, the authors explain.

"These [data] further support the important role of gut microbiota as target of intervention against [infant colic]," they write.

The researchers note that their results align those of an open-label trial in which BB-12, when added to a low-lactose, partially hydrolyzed whey formula, decreased the duration of crying time in infants with colic. Other probiotics as well have reportedly had a beneficial effect on colic.

The study was funded by Sofar SpA, Milan, Italy, which had no role in any aspect of the study. The authors have disclosed no relevant financial relationships.

Aliment Pharmacol Ther. Published online December 4, 2019. Full text

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