背景:早期营养对于肠道菌群的发育至关重要,反过来,在免疫系统的成熟和预防感染中起着至关重要的作用。
目的:这项研究的目的是调查与标准配方相比,在生命的第一年喂养合生元婴儿和后续配方是否降低了感染性腹泻的发病率(IR)。次要终点包括其他传染病的IR以及粪便环境参数。
方法:在这种双盲中,对照试验,460健康,1个月大的婴儿被随机分配接受合生元(低聚半乳糖(GOS)/发酵肝菌CECT5716)(IF,n=230)或控制公式(CF,n=230),直到12个月大。母乳喂养婴儿的参考组(HM,包括n=80)。在整个研究期间记录感染数据,并在4个月和12个月大时收集粪便样本。
结果:生命的第一年感染性腹泻的IR为0.60(CF),0.56(IF)和0.29(HM)组间差别无统计学意义。下呼吸道感染的IR,次要终点之一,然而,IF低于CF(0.79对1.01,IR比=0.77(0.60,1.00))。此外,粪便pH在4个月时显著降低(p<0.0001),而与CF相比,IF中分泌型IgA在12个月大时显着更高(p=0.015)。
结论:尽管腹泻的发生率没有差异,婴儿期食用含有发酵乳杆菌CECT5716和GOS的合生元配方可能会降低下呼吸道感染的发生率,并影响免疫系统和粪便环境。需要进一步研究肠-肺轴的潜在相互作用。
背景:NCT02221687(https://clinicaltrials.gov/ct2/show/NCT02221687)。
Early life nutrition is crucial for the development of the gut microbiota that, in turn, plays an essential role in the maturation of the immune system and the prevention of infections.
The aim of this study was to investigate whether feeding synbiotic infants and follow-on formulas during the first year of life reduces the incidence rate (IR) of infectious diarrhea compared with standard formulas. Secondary endpoints included the IR of other infectious diseases as well as fecal milieu parameters.
In this double-blind, controlled trial, 460 healthy, 1-mo-old infants were randomly assigned to receive a synbiotic [galacto-oligosaccharides (
GOS)/Limosilactobacillus fermentum CECT 5716] (IF, n = 230) or a control formula (CF, n = 230) until 12 mo of age. A reference group of breastfed infants (HM, n = 80) was included. Data on infections were recorded throughout the study period and stool samples were collected at 4 and 12 mo of age.
IR of infectious diarrhea during the first year of life was 0.60 (CF), 0.56 (IF), and 0.29 (HM), with no statistically significant difference between groups. The IR of lower respiratory tract infections, 1 of the secondary endpoints, however, was lower in IF than in CF [0.79 compared with 1.01, IR ratio = 0.77 (0.60-1.00)]. Additionally, fecal pH was significantly lower at 4 mo (P < 0.0001), whereas secretory IgA was significantly higher at 12 mo of age (P = 0.015) in IF compared with CF.
Although no difference is observed in the incidence of diarrhea, consumption of a synbiotic formula containing L. fermentum CECT5716 and
GOS in infancy may reduce the incidence of lower respiratory tract infections and affect the immune system and fecal milieu. Additional research is warranted to further investigate the potential interaction of the gut-lung axis. This trial was registered at clinicaltrials.gov as NCT02221687.