Real-world evidence study on tolerance and growth in infants fed an infant formula with two human milk oligosaccharides vs mixed fed and exclusively breastfed infants.

IF 2.4 Q1 PEDIATRICS
Frank Jochum, Martina Meyer-Krott, Tina Hübler, Maja Lorenz, Raffi Bedikian, Joseph Zakarian, Anja Litzka, Guido Judex, Holger Hertzberg, Daniela Klee, Lothar Maurer, Martin Schacht, Adnan Al-Radhi, Jan Maier, Alexander Kröckel, Christian Faustmann, Luca Lavalle, Samir Dahbane
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Abstract

Introduction: Human milk oligosaccharides (HMOs) are important components of human milk having diverse functions in the development of infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas with the HMOs 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This study aimed to generate real-world evidence (RWE) on growth and gastrointestinal (GI) tolerance in infants consuming a formula with 1 g/L 2'FL and 0.5 g/L LNnT, including a mixed feeding group not studied before in RCTs.

Participants and methods: This 8-week open-label prospective multicenter study was conducted in Germany and Austria, and included groups of healthy, exclusively breastfed infants (BF), exclusively formula-fed infants (FF) who received the HMO-formula, and infants mixed fed with both HMO formula and human milk (MF). Co-primary outcomes were anthropometry and gastrointestinal tolerance via validated Infant Gastrointestinal Symptom Questionnaire (IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs).

Results: One-hundred six infants completed the study (46 FF, 22 MF, and 38 BF). Mean anthropometric z-scores were comparable between groups and generally within ± 0.5 of WHO medians at week 8. IGSQ composite scores demonstrated good GI tolerance in all groups with no significant group differences at week 4 or 8. IGSQ composite scores in FF improved during the course of the study and parents provided high satisfaction ratings for the HMO-formula. Four potentially product-related AEs were reported in FF (no in MF).

Conclusions: In this RWE study examining an infant formula with HMOs, growth and GI tolerance outcomes were confirming the good tolerance and safety of this early feeding option previously reported in RCTs.

Abstract Image

Abstract Image

用两种人乳低聚糖配方奶粉喂养的婴儿与混合喂养和纯母乳喂养的婴儿的耐受性和生长的真实证据研究。
摘要:人乳寡糖(HMOs)是人乳中的重要成分,在婴儿发育过程中具有多种功能。随机对照试验(RCTs)表明,含有HMOs 2′-聚焦乳糖(2′fl)和乳酸-n -新四糖(LNnT)的婴儿配方奶粉是安全的,耐受性良好,并支持正常生长。本研究旨在为食用含有1 g/L 2'FL和0.5 g/L LNnT的配方奶粉的婴儿的生长和胃肠道耐受性提供真实证据(RWE),包括之前未在随机对照试验中研究的混合喂养组。参与者和方法:这项为期8周的开放标签前瞻性多中心研究在德国和奥地利进行,包括健康的纯母乳喂养婴儿(BF),接受HMO配方奶粉的纯配方喂养婴儿(FF),以及HMO配方奶粉和母乳混合喂养的婴儿(MF)。通过婴儿胃肠症状问卷(IGSQ)进行人体测量和胃肠耐受性测试。次要结局包括配方满意度和不良事件(ae)。结果:106名婴儿完成了研究(46名FF, 22名MF, 38名BF)。各组间的平均人体测量z分数具有可比性,通常在第8周时WHO中位数的±0.5范围内。IGSQ综合评分在所有组中显示良好的胃肠道耐受性,在第4周或第8周没有显著的组间差异。在研究过程中,FF的IGSQ综合得分有所提高,家长对HMO-formula的满意度较高。FF中报告了4例可能与产品相关的不良反应(MF中没有)。结论:在这项RWE研究中,研究了一种含有HMOs的婴儿配方奶粉,生长和胃肠道耐受性结果证实了这种早期喂养选择的良好耐受性和安全性,这是之前在随机对照试验中报道的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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