AIM: To investigate recruitment, retention, and estimates for effects of formula supplementation with Lactobacillus rhamnosus GG(LGG) on inflammatory biomarkers and fecal microbial community in infants with colic. MET...
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AIM: To investigate recruitment, retention, and estimates for effects of formula supplementation with Lactobacillus rhamnosus GG(LGG) on inflammatory biomarkers and fecal microbial community in infants with colic. METHODS: A prospective, double-blind, placebocontrolled trial was conducted in otherwise healthy infants with colic. We screened 74 infants and randomized and analyzed results in 20 infants [9 receiving LGG(LGG+) and 11 not receiving LGG(LGG-)]. LGG was incorporated in the formula(Nutramigen~®)(minimum of 3 × 107 CFU/d) in the LGG+ group. Fecal microbiota and inflammatory biomarkers, including fecal calprotectin(FC), plasma cytokines, circulating regulatory T cells(Tregs), and crying + fussing time were analyzed to determine optimal time points and effect sizes for a larger trial. RESULTS: Recruitment in this population was slow, with about 66% of eligible infants willing to enroll; subject retention was better(75%). These rates were influenced by parents' reluctance to volunteer their infant for a clinical trial and by their tendency to change formulas. The maximal difference of crying + fussing time was observed at day 14, comparing the 2 groups, with a mean difference of-91(95%CI:-76, 259) min(P = NS). FC showed no significant difference, but the optimal time to determine a potential effect was at day 90 [with a mean difference of 121(95%CI:-48, 291) μg/g stool], observing a lower level of FC in the LGG+ group. The fecal microbial communities were chaotic, as determined by Shannon's diversity index and not apparently influenced by the probiotic. No significant change was observed in plasma inflammatory cytokines or Tregs, comparing LGG+ to LGG- groups. CONCLUSION: Designing future colic trials involving a probiotic-supplemented formula for infants in the United States will require consideration for difficult enrollment. Infants with colic have major variations in feal microbiota and calprotectin, both of which improve with time, with optimal time p
Objective. To analyze the predictive effect on obstetrical outcome in women with prenatal exposure to diethylstilbestrol (DES) of previous obstetrical history or the specific risk of DES exposure. Patients and methods...
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Objective. To analyze the predictive effect on obstetrical outcome in women with prenatal exposure to diethylstilbestrol (DES) of previous obstetrical history or the specific risk of DES exposure. Patients and methods. We included all in utero DES- exposed women (454 women) followed and delivered at one maternity unit in Paris and compared them with two control women matched for age, parity, number of late fetal losses, number of previous preterm births, number of singleton or twin fetuses, and follow- up, who were managed by the same team or referred for pregnancy complication. Results. DES women had a higher rate of preterm birth (19.2% ) than matched controls (10.5% ), even when considering women with a previous preterm birth or twin pregnancy. The rate of fetal or neonatal deaths were lower in DES- exposed women than in controls. DES women showed a higher rate of severe post partum bleeding (2.8% ) than matched controls (1.5% ) or the global population of women delivered in this maternity unit. Conclusion. A history of prenatal exposure to DESis a major predictor of preterm birth for primiparous women and for those with an adverse obstetrical history.
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