A Pilot analysis of early lactobacillus rhamnosus GG for infant colic prevention

We conducted a secondary analysis of data from a trial of Lactobacillus rhamnosus GG (LGG) supplementation as a pilot study to assess whether LGG prevents infant colic. For the first 6 months of life, infants received a daily dose of 10 billion colony-forming units of LGG or a control (n = 184). We compared the likelihood of a diagnosis of colic before 4 months of age, based on parent reported symptoms or a physician diagnosis of colic. Out of the 184 infants, 18 (9.8%) had colic. There were no differences between the two groups in the percentage of infants with colic based on symptoms (control 5.4% vs. LGG 9.8%; p = 0.19); physician diagnosis (control 3.2% vs. LGG 7.6%; p = 0.26); or either symptoms or diagnosis combined (control 6.5% vs. LGG 13.0%; p = 0.13). In this pilot study, early infant LGG supplementation does not appear to prevent the later development of colic. Address correspondence and reprint requests to Michael D. Cabana, MD, MPH, 3333 California Street, Laurel Heights Bldg #245, San Francisco, CA 94118 (e-mail: michael.cabana@ucsf.edu). Received 19 October, 2017 Accepted 24 May, 2018 Contributors' Statements Michael D. Cabana, MD, MPH: Dr. Cabana conceptualized and designed the study, designed the data collection instruments, interpreted the data and analyses, drafted the initial manuscript and approved the final manuscript as submitted. Michelle McKean, RD, MPH: Ms. McKean designed the study, supervised and coordinated the overall data collection, interpreted the data and analyses, critically reviewed the manuscript and approved the final manuscript as submitted. Amy L. Beck, MD, MPH interpreted the data and analyses, critically reviewed the manuscript and approved the final manuscript as submitted. Valerie Flaherman, MD, MPH assisted with the data analysis, interpreted the data and analyses, critically reviewed the manuscript and approved the final manuscript as submitted. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. Financial Disclosure: The authors have no financial relationships relevant to this article to disclose. Funding Source: Funded by the National Institutes of Health (HL 080074) and the Clinical and Translational Science Institute (UL1 RR024131) at UCSF. Conflict of Interest: MDC has served as a paid consultant for Biogaia AB (Stockholm, Sweden). Clinical Trial Registration: ClinicalTrials.gov identifier: NCT00113659 Abbreviations: CAindicates California; CFU; Colony forming units; CI Confidence interval; CT, Connecticut; HRHazard ratio; LGGLactobacillus rhamnosus GG; SDStandard deviation; TIPSTrial of Infant Probiotic Supplementation; UCSFUniversity of California; San Francisco; USUnited States © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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