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IntroductionLacticaseibacillus rhamnosus GG (LGG) is a well-studied probiotic with a history of safe use.MethodsIn this double-blind, prospective study, growth and tolerance were evaluated in healthy term infants randomized to: marketed, routine intact cow's milk protein-based formula (Control, n = 172) or a similar investigational formula with added LGG (INV-LGG, n = 179; 106 CFU LGG®/g powder) from 14 to 120 days of age. Anthropometrics, stool characteristics, fussiness, and gassiness were evaluated through Day 120. Medically confirmed adverse events were recorded throughout the study period. The primary outcome was rate of weight gain from Day 14–120.ResultsOf 351 infants enrolled, 275 completed (Control, n = 131; INV-LGG, n = 144). No significant group differences in rate of weight gain from Day 14–120 were detected. Study formula acceptance and tolerance was good with no significant differences in study discontinuation due to study formula or parent-reported gassiness, stool frequency, or stool consistency; however mean fussiness relative to normal was significantly lower for INV-LGG vs Control at Days 60 and 90.DiscussionIn healthy term infants, a routine intact cow's milk protein-based formula with added LGG supported adequate growth and was well tolerated. Further studies are needed to evaluate potential benefits for fussiness and efficacy outcomes. Clinical Trial RegistrationClinicaltrials.gov, identifier (NCT01897922).

Abstract Background Early infant feeding with intact or extensively hydrolyzed (EH) proteins or free amino acids (AA) may differentially affect intestinal microbiota composition and immune reactivity. This multicenter, double-blind, controlled, parallel-group, pilot study compared stool microbiota from Baseline (1–7 days of age) up to 60 days of age in healthy term infants who received mother’s own milk (assigned to human milk [HM] reference group) (n = 25) or were randomized to receive one of two infant formulas: AA-based (AAF; n = 25) or EH cow’s milk protein (EHF; n = 28). Stool samples were collected (Baseline, Day 30, Day 60) and 16S rRNA genes were sequenced. Alpha (Shannon, Simpson, Chao1) and beta diversity (Bray Curtis) were analyzed. Relative taxonomic enrichment and fold changes were analyzed (Wilcoxon, DESEq2). Short/branched chain fatty acids (S/BCFA) were quantified by gas chromatography. Mean S/BCFA and pH were analyzed (repeated measures ANOVA). Results At baseline, alpha diversity measures were similar among all groups; however, both study formula groups were significantly higher versus the HM group by Day 60. Significant group differences in beta diversity at Day 60 were also detected, and study formula groups were compositionally more similar compared to HM. The relative abundance of Bifidobacterium increased over time and was significantly enriched at Day 60 in the HM group. In contrast, a significant increase in members of Firmicutes for study formula groups were detected at Day 60 along with butyrate-producing species in the EHF group. Stool pH was significantly higher in the AAF group at Days 30 and 60. Butyrate increased significantly from Baseline to Day 60 in the EHF group and was significantly higher in study formula groups vs HM at Day 60. Propionate was also significantly higher for EHF and AAF at Day 30 and AAF at Day 60 vs HM. Total and individual BCFA were higher for AAF and EHF groups vs HM through Day 60. Conclusions Distinct patterns of early neonatal microbiome, pH, and microbial metabolites were demonstrated for infants receiving mother’s own milk compared to AA-based or extensively hydrolyzed protein formula. Providing different sources of dietary protein early in life may influence gut microbiota and metabolites. Trial registration ClinicalTrials.gov Identifier: NCT02500563 . Registered July 28, 2015.

Abstract??The duration of gastroesophageal reflux disease (GERD) is an important factor in the development of esophageal complications. The objective of this study was to examine in a retrospective, case-controlled manner the prevalence of GERD in adults who were diagnosed with GERD in infancy or early childhood. Infants and children with nonsyndromic GERD diagnosed by an experienced pediatric gastroenterologist from 1976 to 1980 and control subjects seen for well-child care from 1980 to 1985 were included in this study. The subjects were located and contacted by telephone or mail and administered a brief structured questionnaire relating to their current history of GERD. GERD-A was defined as weekly heartburn or regurgitation of any severity, and GERD-B was defined as monthly heartburn or regurgitation greater than mild in severity. Sixty-five participants (31 patients and 34 controls) returned completed questionnaires and were subdivided into the three study groups as follows: Infant (15), Child (16), and Control (34). The prevalence of adulthood GERD-A was 13, 31, and 21% in the Infant, Child, and Control groups, respectively. Similarly, the prevalence of adulthood GERD-B was 20%, 44%, and 24%, respectively. The Child group tended to report more severe heartburn than the other groups. The Infant group tended to report more frequent regurgitation, and the Child group also reported a higher prevalence of nocturnal heartburn and more frequent use of GERD medications, although these were not statistically significant. These data suggest that pediatric GER is a heterogeneous disorder and that GERD occurringafterinfancy may be more predictive of the presence of GERD during adulthood. Longitudinal follow-up of a larger number of children is needed to answer the question of when classic adulthood GERD begins. [ABSTRACT FROM AUTHOR]