Written by Angeline A. De Leon, Staff Writer. Study suggests that probiotic supplementation with BB-12® can effectively alleviate the symptoms of infant colic in very young breastfed infants.

women's healthInfant colic (IC), characterized by frequent, prolonged, and intense crying in an otherwise healthy infant, impacts nearly a quarter of all infants within the first 3 months of life 1,2. Much remains unknown regarding the etiology of IC, however, emerging evidence indicates that alterations in gastrointestinal function may be involved 3,4. Specifically, distinct changes in the diversity and stability of gut microbiota have been documented in infants with IC just weeks after birth 5. By influencing the regulation of neural, endocrine, and immune signaling pathways, gut dysbiosis (microbial imbalance) may critically contribute to the manifestation of IC symptoms 6. Evidence suggests, therefore, that the therapeutic use of probiotics may be helpful in the management of IC symptoms. Bifidobacterium animalis subsp. lactis (BB-12®) is a well-researched probiotic known for its ability to modulate gut microbiota and bolster immune system function 7. In a previous investigation, BB-12®, when added to a low-lactose formula containing prebiotics, was found to effectively reduce crying duration in infants with IC 8. In a follow-up investigation 9 on the efficacy of BB-12®, researchers in Italy (2019) examined the relationship between BB-12® supplementation and average crying time in infants with IC.

A total of 80 exclusively breastfed infants (aged 7 weeks or younger) with symptoms of IC (episodes of irritability, fussing, or crying lasting 3 or more hours per day for at least 3 days per week) were enrolled in a randomized, double-blind, placebo-controlled trial. Infants were randomized to receive either parental reassurance and education plus BB-12® (1 x 109 CFU/daily) or parental reassurance and education plus placebo for 28 days. Parents completed a daily log recording number and duration of crying episodes, number of bowel movements, consistency of stool, and sleep duration. At the time of enrollment and after 4 weeks of treatment, stool samples were collected from a subset of infants and analyzed for gut microbiota structure and fecal levels of human beta-defensin 2 (HBD-2, antimicrobial peptide), cathelicidin (LL-37, antimicrobial peptide), secretory IgA (slgA, major antibody), calprotectin (marker of intestinal inflammation), and butyrate (anti-inflammatory short-chain fatty acids).

Results of the study indicated that at the end of treatment, BB-12® infants had a significantly greater reduction in crying duration, compared to placebo (p < 0.0001). Overall rate of responders (50% or greater reduction in mean daily crying duration) was significantly higher in BB-12® infants starting in Week 3 (p < 0.05). Mean change in number of crying episodes per day from baseline to Day 28 was also significantly greater for the BB-12® group vs. placebo (-4.7 +/- 3.4 vs. -2.3 +/- 2.2, p = 0.001). In addition, fecal analyses revealed a significant increase in Bifidobacterium abundance (p < 0.05) and fecal levels of butyrate, HBD-2, LL-37, and slgA, along with a significant decrease in calprotectin associated with BB-12® (p < 0.05 on all parameters).

Evidence from the present study suggests that probiotic supplementation, with BB-12® specifically, can effectively alleviate symptoms of IC in infants. BB-12® treatment was seen to produce significant improvements in crying duration and number of crying episodes per day as early as after 3 weeks of supplementation.  Additionally, analyses of stool samples from infants revealed that treatment with BB-12® was associated with an increase in biomarkers of immunity (HBD-2, LL-37, and slgA), indicative of an immunomodulatory effect, along with greater production of butyrate, a well-known beneficial bacteria. Infants receiving BB-12® also demonstrated greater relative abundance of Bifidobacterium and a reduction in calprotectin, suggesting modulation of microbiota profile and lower levels of inflammation. Overall, based on the present study, BB-12® appears to offer a promising strategy for therapeutic management of IC; however, study limitations for consideration include a relatively small sample size and the absence of data on formula feeding infants. Future studies will also need to further examine the efficacy of BB-12® in comparison to other probiotic strains. An add-on to this type of study would be to compare the skin bacteria on the breasts of the mothers of colic and non-colic infants.

Source: Nocerino R, De Filippis F, Cecere G, et al. The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12® in infant colic: a randomized, double-blind, placebo-controlled trial.  Alimentary Pharmacology & Therapeutics. 2019; 00: 1-11. DOI: 10.1111/apt.15561.

© 2019 The Authors. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Posted December 30, 2019.

Angeline A. De Leon, MA, graduated from the University of Illinois at Urbana-Champaign in 2010, completing a bachelor’s degree in psychology, with a concentration in neuroscience. She received her master’s degree from The Ohio State University in 2013, where she studied clinical neuroscience within an integrative health program. Her specialized area of research involves the complementary use of neuroimaging and neuropsychology-based methodologies to examine how lifestyle factors, such as physical activity and meditation, can influence brain plasticity and enhance overall connectivity.

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