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

摘要

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.