Hypoallergenic formula with Lactobacillus rhamnosus GGfor babies with colic:A pilot study of recruitment,retention,and fecal biomarkers

AIM To investigate recruitment, retention, and estimatesfor effects of formula supplementation withLactobacillus rhamnosus GG （LGG） on inflammatorybiomarkers and fecal microbial community in infants withcolic.METHODS： A prospective, double-blind, placebocontrolledtrial was conducted in otherwise healthyinfants with colic. We screened 74 infants and randomizedand analyzed results in 20 infants [9 receivingLGG （LGG＋） and 11 not receiving LGG （LGG-）]. LGG wasincorporated in the formula （Nutramigen？） （minimum of3 × 10^7 CFU/d） in the LGG＋ group. Fecal microbiota andinflammatory biomarkers, including fecal calprotectin（FC）, plasma cytokines, circulating regulatory T cells（Tregs）, and crying ＋ fussing time were analyzed todetermine optimal time points and effect sizes for alarger trial.RESULTS： Recruitment in this population was slow, withabout 66% of eligible infants willing to enroll; subjectretention was better （75%）. These rates were influencedby parents＇ reluctance to volunteer their infant for aclinical trial and by their tendency to change formulas.The maximal difference of crying ＋ fussing time wasobserved at day 14, comparing the 2 groups, with amean difference of -91 （95%CI： -76, 259） min （P = NS）.FC showed no significant difference, but the optimaltime to determine a potential effect was at day 90 [witha mean difference of 121 （95%CI： -48, 291） μg/g stool],observing a lower level of FC in the LGG＋ group. Thefecal microbial communities were chaotic, as determinedby Shannon＇s diversity index and not apparently influencedby the probiotic. No significant change wasobserved in plasma inflammatory cytokines or Tregs,comparing LGG＋ to LGG- groups.CONCLUSION： Designing future colic trials involving aprobiotic-supplemented formula for infants in the UnitedStates will require consideration for difficult enrollment.Infants with colic have major variations in feal microbiotaand calprotectin, both of which improve with time, withoptimal time points for measurement at days 14 and 90after treatment.

Burden of nonalcoholic fatty liver disease and advanced fibrosis in a Texas Hispanic community cohort

AIM: To investigate the potential burden of nonalcoholic steatohepatitis(NASH) and advanced fibrosis in a hispanic community.METHODS: Four hundred and forty two participants with available ultrasonography data from the Cameron County Hispanic Cohort were included in this study. Each participant completed a comprehensive questionnaire regarding basic demographic information, medical history, medication use, and social and family history including alcohol use. Values of the nonalcoholic fatty liver disease fibrosis score(NFS), FIB4 index, BARD score, and Aspartate aminotransferase to Platelet Ratio Index(APRI) were computed using the blood samples collected within 6 mo of liver ultrasonography from each participant. Hepatic steatosis was determined by ultrasonography. As part of univariable analysis, for continuous variables, comparisons among groups were performed with student-t test, one way analysis of variance, and Mann-Whitney test. Pearson χ2 and the Fisher exact test are used to assess differences in categorical variables. For multivariable analyses, logistic regression analyses were performed to identify characteristics associated with hepatic steatosis. All reported P values are based two-sided tests, and a P value of less than 0.05 was considered to indicate statistical significance.RESULTS: The mean age and body mass index(BMI) of the study participants were 49.1 years and 31.3 kg/m2, respectively. Among them, 65.6% were females, 52% had hepatic steatosis, 49.5% had metabolic syndrome, and 29% had elevated aminotransferases. Based on established cut-offs for diagnostic panels, between 17%-63% of the entire cohort was predicted to have NASH with indeterminate or advanced fibrosis. Participants with hepatic steatosis had significantly higher BMI(32.9 ± 5.6 kg/m2 vs 29.6 ± 6.1 kg/m2, P < 0.001) and higher prevalence rates of elevation of ALT(42.2% vs 14.6%, P < 0.001), elevation of aspartate aminotransferase(38.7% vs 18.9%, P < 0.001), and metabolic syndrome(64.8% vs 33%, P < 0.001) than those without hepatic steatosis. The NFS scores(P = 0.002) and the APRI scores(P = 0.002) were significantly higher in those with steatosis but the scores of the FIB4 index and BARD were similar between the two groups. After adjusting for age, gender and BMI, elevated transaminases, metabolic syndrome and its components, intermediate NFS and APRI scores were associated hepatic steatosis in multivariable analysis. CONCLUSION: The burden of NASH and advanced fibrosis in the Hispanic community in South Texas may be more substantial than predicted from referral clinic studies.