Baylor College of Medicine, One Baylor Plaza, Houston, TX, 77030, USA.
Center for Pediatric Abdominal Pain Research, Baylor College of Medicine, Houston, TX, 77030, USA.
BMC Pediatr. 2022 Oct 7;22(1):580. doi: 10.1186/s12887-022-03647-x.
Our aim was to evaluate infant behavioral state, stool microbiome profile and calprotectin in infants with infantile colic receiving a partially hydrolyzed protein formula with or without added Lacticaseibacillus (formerly Lactobacillus) rhamnosus GG (LGG).
In this single-center, double-blind, controlled, parallel, prospective study, term infants (14-28 days of age) identified with colic (using modified Wessel's criteria: cried and/or fussed ≥ 3 h/day for ≥ 3 days/week, in a one-week period) were randomized to receive one of two formulas over a three-week feeding period: marketed partially hydrolyzed cow's milk-based infant formula (PHF, n = 35) or a similar formula with added LGG (PHF-LGG, n = 36). Parent-reported infant behavior was recorded at three time points (Study Days 2-4, 10-12, and 18-20). Duration (hours/day) of crying/fussing (averaged over each three-day period) was the primary outcome. Stool samples were collected at Baseline and Study End (Days 19-21) to determine stool LGG colonization (by qPCR) and microbial abundance (using 16S rRNA gene sequencing) and calprotectin (μg/g).
Duration of crying/fussing (mean ± SE) decreased and awake/content behavior increased over time with no significant group differences over the course of the study. There were no group differences in the percentage of infants who experienced colic by study end. Colic decreased by Study End vs Baseline in both groups. Change in fecal calprotectin also was similar between groups. Comparing Study End vs Baseline, LGG abundance was greater in the PHF-LGG group (P < 0.001) whereas alpha diversity was greater in the PHF group (P = 0.022). Beta diversity was significantly different between PHF and PHF-LGG at Study End (P = 0.05). By study end, relative abundance of L. rhamnosus was higher in the PHF-LGG vs PHF group and vs Baseline.
In this pilot study of infants with colic, both study formulas were well tolerated. Crying/fussing decreased and awake/content behavior increased in both study groups over the course of the study. Study results demonstrate a successful introduction of the probiotic to the microbiome. The partially hydrolyzed protein formula with added LGG was associated with significant changes in the gut microbiome.
ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT02340143 . Registered 16/01/2015.
我们的目的是评估婴儿的行为状态、粪便微生物群谱和钙卫蛋白，这些都是患有婴儿绞痛的婴儿在接受部分水解蛋白配方（含或不含添加的鼠李糖乳杆菌（Lactobacillus rhamnosus GG，LGG））后的表现。
在这项单中心、双盲、对照、平行、前瞻性研究中，我们选择了 14-28 天龄、被诊断为绞痛的足月婴儿（采用改良的韦塞尔标准：每周哭/闹时间≥3 小时/天≥3 天），随机分配至接受两种配方中的一种喂养三周：市售部分水解牛奶基婴儿配方（PHF，n=35）或类似配方添加 LGG（PHF-LGG，n=36）。在三个时间点（研究第 2-4 天、第 10-12 天和第 18-20 天）记录父母报告的婴儿行为。主要结局是每天哭泣/哭闹的时长（每三天的平均值）。在基线和研究结束时（第 19-21 天）采集粪便样本，以确定粪便 LGG 定植情况（qPCR 法）和微生物丰度（16S rRNA 基因测序法）和钙卫蛋白（μg/g）。
随着时间的推移，哭泣/哭闹的时长（平均值±标准误）逐渐减少，清醒/活跃行为逐渐增加，研究过程中两组间无显著差异。研究结束时，两组出现绞痛的婴儿比例无差异。与基线相比，两组绞痛均在研究结束时减轻。粪便钙卫蛋白也有类似的变化。与基线相比，研究结束时 PHF-LGG 组的 LGG 丰度更高（P<0.001），而 PHF 组的 alpha 多样性更高（P=0.022）。研究结束时，PHF 和 PHF-LGG 之间的 beta 多样性存在显著差异（P=0.05）。研究结束时，与 PHF 组和基线相比，PHF-LGG 组的 L. rhamnosus 相对丰度更高。
在这项患有绞痛的婴儿的试点研究中，两种研究配方均具有良好的耐受性。在研究过程中，两组婴儿的哭泣/哭闹时间减少，清醒/活跃行为增加。研究结果表明益生菌成功引入了肠道微生物群。添加 LGG 的部分水解蛋白配方与肠道微生物群的显著变化有关。
ClinicalTrials.gov，ClinicalTrials.gov 标识符：NCT02340143。注册于 2015 年 1 月 16 日。
