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.

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.

Real-world study in infants fed with an infant formula with two human milk oligosaccharides / Estudio en condiciones reales de lactantes alimentados con una fórmula infantil con dos oligosacáridos de leche humana

INTRODUCTION: human milk oligosaccharides (HMOs) are an important component of human milk supporting the development of a balanced intestinal microbiota and immune protection in breastfed infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas supplemented with the HMOs 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This Real-World Evidence (RWE) study aimed to evaluate growth and tolerance in infants consuming a formula supplemented with 1 g/L of 2'FL and 0.5 g/L of LNnT, and included a mixed-feeding group never studied before in RCTs. Participants and methods: this open-label, prospective study was conducted at six centers in Spain, and included healthy, exclusively breastfed infants (BF group), an exclusively formula-fed group (FF) who received a milk-based formula with 2' FL and LNnT, and a group mixed fed with both formula and human milk (MF), for 8 weeks. Co-primary outcomes were growth (anthropometry) and gastrointestinal tolerance (Infant Gastrointestinal Symptom Questionnaire, IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs). RESULTS: 159 infants completed the study (66 FF, 48 MF, and 45 BF). Mean z-scores for growth were similar between all groups and within ± 0.5 of WHO medians at week 8. Composite IGSQ scores demonstrated low GI distress in all groups, with no significant group differences at baseline, week 4, or week 8. Incidence of AEs was low overall, and comparable across groups. CONCLUSIONS: in this RWE study examining a HMO-supplemented infant formula, growth and tolerance outcomes were similar to RCT findings, supporting the effectiveness of this early feeding option

INTRODUCCIÓN: los oligosacáridos de la leche materna (HMO) contribuyen a desarrollar la inmunoprotección y la microbiota intestinal. Los ensayos aleatorizados (RCT) han demostrado que las fórmulas enriquecidas con 2'fucosilactosa (2'FL) y lacto-N-neotetraosa (LNnT) son seguras, bien toleradas y favorecen el crecimiento. El objetivo de este estudio ha sido valorar el crecimiento, la seguridad y la tolerancia digestiva en lactantes alimentados con una fórmula enriquecida con 1 g/L de 2'FL y 0,5 g/L de LNnT, con datos de la vida real (RWE), incluyendo un grupo de alimentación mixta no estudiado antes en los RCT. Participantes y métodos: estudio prospectivo abierto en seis hospitales españoles que incluyó lactantes sanos alimentados con leche materna (BF), con fórmula enriquecida en 2'FL y LNnT (FF) o con mezcla de ambas (MF), durante ocho semanas. Se valoraron el crecimiento (antropometría), la tolerancia gastrointestinal (cuestionario IGSQ) y los acontecimientos adversos. RESULTADOS: 159 lactantes completaron el estudio (66, 48 y 45, en los grupos FF, MF y BF, respectivamente). Las puntuaciones Z antropométricas a la semana 8 fueron similares entre los grupos y se hallaron dentro del rango de ± 0,5 de la normalidad. Las puntuaciones IGSQ compuestas mostraron un bajo malestar digestivo, sin diferencias significativas entre los grupos, al inicio y en las semanas 4 y 8. La incidencia de eventos adversos fue baja y comparable entre los grupos. CONCLUSIONES: en este estudio RWE que evaluó una fórmula para lactantes enriquecida en HMO, los resultados sobre el crecimiento, la tolerancia y la seguridad fueron similares a los obtenidos en los RCT, respaldando su eficacia como alimentación temprana opcional

Real-world study in infants fed with an infant formula with two human milk oligosaccharides.

Introduction: Introduction: human milk oligosaccharides (HMOs) are an important component of human milk supporting the development of a balanced intestinal microbiota and immune protection in breastfed infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas supplemented with the HMOs 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This Real-World Evidence (RWE) study aimed to evaluate growth and tolerance in infants consuming a formula supplemented with 1 g/L of 2'FL and 0.5 g/L of LNnT, and included a mixed-feeding group never studied before in RCTs. Participants and methods: this open-label, prospective study was conducted at six centers in Spain, and included healthy, exclusively breastfed infants (BF group), an exclusively formula-fed group (FF) who received a milk-based formula with 2' FL and LNnT, and a group mixed fed with both formula and human milk (MF), for 8 weeks. Co-primary outcomes were growth (anthropometry) and gastrointestinal tolerance (Infant Gastrointestinal Symptom Questionnaire, IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs). Results: 159 infants completed the study (66 FF, 48 MF, and 45 BF). Mean z-scores for growth were similar between all groups and within ± 0.5 of WHO medians at week 8. Composite IGSQ scores demonstrated low GI distress in all groups, with no significant group differences at baseline, week 4, or week 8. Incidence of AEs was low overall, and comparable across groups. Conclusions: in this RWE study examining a HMO-supplemented infant formula, growth and tolerance outcomes were similar to RCT findings, supporting the effectiveness of this early feeding option.

Introducción: Introducción: los oligosacáridos de la leche materna (HMO) contribuyen a desarrollar la inmunoprotección y la microbiota intestinal. Los ensayos aleatorizados (RCT) han demostrado que las fórmulas enriquecidas con 2'fucosilactosa (2'FL) y lacto-N-neotetraosa (LNnT) son seguras, bien toleradas y favorecen el crecimiento. El objetivo de este estudio ha sido valorar el crecimiento, la seguridad y la tolerancia digestiva en lactantes alimentados con una fórmula enriquecida con 1 g/L de 2'FL y 0,5 g/L de LNnT, con datos de la vida real (RWE), incluyendo un grupo de alimentación mixta no estudiado antes en los RCT. Participantes y métodos: estudio prospectivo abierto en seis hospitales españoles que incluyó lactantes sanos alimentados con leche materna (BF), con fórmula enriquecida en 2'FL y LNnT (FF) o con mezcla de ambas (MF), durante ocho semanas. Se valoraron el crecimiento (antropometría), la tolerancia gastrointestinal (cuestionario IGSQ) y los acontecimientos adversos. Resultados: 159 lactantes completaron el estudio (66, 48 y 45, en los grupos FF, MF y BF, respectivamente). Las puntuaciones Z antropométricas a la semana 8 fueron similares entre los grupos y se hallaron dentro del rango de ± 0,5 de la normalidad. Las puntuaciones IGSQ compuestas mostraron un bajo malestar digestivo, sin diferencias significativas entre los grupos, al inicio y en las semanas 4 y 8. La incidencia de eventos adversos fue baja y comparable entre los grupos. Conclusiones: en este estudio RWE que evaluó una fórmula para lactantes enriquecida en HMO, los resultados sobre el crecimiento, la tolerancia y la seguridad fueron similares a los obtenidos en los RCT, respaldando su eficacia como alimentación temprana opcional.