Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial
Background and aimsGut health and microbiome development are closely linked in early life, with human milk oligosaccharides (HMOs) playing a key role. This study reports results through 4 months of age from a trial evaluating an infant formula containing a synbiotic blend of HMOs and probiotics, foc...
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Frontiers Media S.A.
2025-07-01
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| author | Jean-Charles Picaud Jean-Charles Picaud Olivier Claris Mercedes Gil-Campos Ignacio Salamanca De La Cueva Luc Cornette Philippe Alliet André Léké Mireille Castanet Hugues Piloquet Virginie de Halleux Delphine Mitanchez Yvan Vandenplas Pierre Maton Frank Jochum Dirk Olbertz Sergio Negre Policarpo Luca Lavalle Cecilia Fumero Paula Rodriguez-Garcia Janne Marie Moll Irma Silva-Zolezzi Boutaina Zemrani Nicholas P. Hays Norbert Sprenger Javier Miranda-Mallea |
| author_facet | Jean-Charles Picaud Jean-Charles Picaud Olivier Claris Mercedes Gil-Campos Ignacio Salamanca De La Cueva Luc Cornette Philippe Alliet André Léké Mireille Castanet Hugues Piloquet Virginie de Halleux Delphine Mitanchez Yvan Vandenplas Pierre Maton Frank Jochum Dirk Olbertz Sergio Negre Policarpo Luca Lavalle Cecilia Fumero Paula Rodriguez-Garcia Janne Marie Moll Irma Silva-Zolezzi Boutaina Zemrani Nicholas P. Hays Norbert Sprenger Javier Miranda-Mallea |
| author_sort | Jean-Charles Picaud |
| collection | DOAJ |
| description | Background and aimsGut health and microbiome development are closely linked in early life, with human milk oligosaccharides (HMOs) playing a key role. This study reports results through 4 months of age from a trial evaluating an infant formula containing a synbiotic blend of HMOs and probiotics, focusing on growth, gastrointestinal (GI) tolerance, and gut health biomarkers from birth to 15 months.Materials and methodsHealthy infants aged ≤14 days were randomized to receive either the experimental formula (SYN; control formula supplemented with six HMOs and two probiotics [B. infantis, B. lactis]) or the control formula (CTRL; partially hydrolyzed 100% whey-based formula). A non-randomized breastfed (BF) group served as a reference. The primary endpoint was weight gain velocity in SYN vs. CTRL through 4 months of age. Secondary endpoints included fecal outcomes (abundance of bifidobacteria, immune and gut health markers), GI tolerance, and adverse events (AEs).ResultsThe full analysis set (FAS) included 313 infants (118 in SYN, 114 in CTRL, and 81 BF), while the per-protocol population (PP) included 227 infants (84 in SYN, 84 in CTRL, and 59 BF). Weight gain velocity through 4 months in the SYN group was non-inferior to that in the CTRL group in both FAS and PP analyses (both p < 0.0001). Parent-reported GI tolerance and stool patterns were similar between SYN and CTRL groups through 4 months. At 3 months, Bifidobacteria abundance was significantly higher in the SYN group compared to the CTRL group (p = 0.004). Fecal pH was lower in the SYN group than in the CTRL group (p = 0.018) and more closely resembled that of the BF group. Immune and gut health markers were similar between the SYN and BF groups. No significant differences in AEs were observed across groups.ConclusionThe synbiotic-supplemented infant formula supported healthy, age-appropriate growth, good GI tolerance, and increased the abundance of beneficial bifidobacteria through 4 months of age.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT04962594. |
| format | Article |
| id | doaj-art-40d9ff9a590940e18b2313f60f35d656 |
| institution | Matheson Library |
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| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Nutrition |
| spelling | doaj-art-40d9ff9a590940e18b2313f60f35d6562025-07-23T04:13:05ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2025-07-011210.3389/fnut.2025.16288471628847Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trialJean-Charles Picaud0Jean-Charles Picaud1Olivier Claris2Mercedes Gil-Campos3Ignacio Salamanca De La Cueva4Luc Cornette5Philippe Alliet6André Léké7Mireille Castanet8Hugues Piloquet9Virginie de Halleux10Delphine Mitanchez11Yvan Vandenplas12Pierre Maton13Frank Jochum14Dirk Olbertz15Sergio Negre Policarpo16Luca Lavalle17Cecilia Fumero18Paula Rodriguez-Garcia19Janne Marie Moll20Irma Silva-Zolezzi21Boutaina Zemrani22Nicholas P. Hays23Norbert Sprenger24Javier Miranda-Mallea25Department of Neonatology, Hôpital de La Croix-Rousse, Lyon, FranceCarMen Laboratory, INSERM, INRA, Université Claude Bernard Lyon 1, Pierre-Bénite, Lyon, FranceDepartment of Neonatology, Hôpital Femme Mère Enfants, Bron, FrancePaediatric Metabolism Unit, Reina Sofia University Hospital, University of Córdoba, IMIBIC, CIBEROBN, Córdoba, SpainDepartment of Pediatrics, Instituto Hispalense de Pediatria, Sevilla, SpainDepartment of Neonatology, AZ Sint-Jan Hospital, Brugge, BelgiumDepartment of Pediatrics, Jessa Hospital, Hasselt, BelgiumNeonatal Medicine and Intensive Care, Centre Hospitalier Universitaire Amiens Picardie, Amiens, FranceCIC INSERM U1404, Department of Pediatrics, Rouen University Hospital Charles Nicole, Rouen, France0Child Chronic Disease Service, Centre Hospitalier Universitaire de Nantes, Nantes, France1Neonatology Division, Centre Hospitalier Universitaire de Liège – Centre Hospitalier Universitaire de la Citadelle, Liège, Belgium2Service de Néonatologie, Centre Hospitalier Universitaire de Tours, Tours, France3KidZ Health Castle, Vrije Universiteit Brussel, UZ Brussel, Brussels, Belgium4Service Néonatal, Clinique CHC-Montlégia, Liège, Belgium5Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany6Department of Neonatology, Klinikum Südstadt Rostock, Rostock, Germany7Department of Pediatrics, Hospital Quironsalud, Valencia, Spain8Clinical Research Unit, Nestlé Research, Lausanne, Switzerland8Clinical Research Unit, Nestlé Research, Lausanne, Switzerland9Cmbio, Copenhagen, Denmark9Cmbio, Copenhagen, Denmark0Clinical and Nutritional Research Unit, Nestlé Product Technology Center – Nutrition, Vevey, Switzerland0Clinical and Nutritional Research Unit, Nestlé Product Technology Center – Nutrition, Vevey, Switzerland0Clinical and Nutritional Research Unit, Nestlé Product Technology Center – Nutrition, Vevey, Switzerland1Nestlé Institute of Health Sciences, Nestlé Research, Lausanne, Switzerland2Department of Pediatrics, Hospital Vithas, Valencia, SpainBackground and aimsGut health and microbiome development are closely linked in early life, with human milk oligosaccharides (HMOs) playing a key role. This study reports results through 4 months of age from a trial evaluating an infant formula containing a synbiotic blend of HMOs and probiotics, focusing on growth, gastrointestinal (GI) tolerance, and gut health biomarkers from birth to 15 months.Materials and methodsHealthy infants aged ≤14 days were randomized to receive either the experimental formula (SYN; control formula supplemented with six HMOs and two probiotics [B. infantis, B. lactis]) or the control formula (CTRL; partially hydrolyzed 100% whey-based formula). A non-randomized breastfed (BF) group served as a reference. The primary endpoint was weight gain velocity in SYN vs. CTRL through 4 months of age. Secondary endpoints included fecal outcomes (abundance of bifidobacteria, immune and gut health markers), GI tolerance, and adverse events (AEs).ResultsThe full analysis set (FAS) included 313 infants (118 in SYN, 114 in CTRL, and 81 BF), while the per-protocol population (PP) included 227 infants (84 in SYN, 84 in CTRL, and 59 BF). Weight gain velocity through 4 months in the SYN group was non-inferior to that in the CTRL group in both FAS and PP analyses (both p < 0.0001). Parent-reported GI tolerance and stool patterns were similar between SYN and CTRL groups through 4 months. At 3 months, Bifidobacteria abundance was significantly higher in the SYN group compared to the CTRL group (p = 0.004). Fecal pH was lower in the SYN group than in the CTRL group (p = 0.018) and more closely resembled that of the BF group. Immune and gut health markers were similar between the SYN and BF groups. No significant differences in AEs were observed across groups.ConclusionThe synbiotic-supplemented infant formula supported healthy, age-appropriate growth, good GI tolerance, and increased the abundance of beneficial bifidobacteria through 4 months of age.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT04962594.https://www.frontiersin.org/articles/10.3389/fnut.2025.1628847/fullbifidobacteriagastrointestinal tolerancegrowthgut healthmicrobiota |
| spellingShingle | Jean-Charles Picaud Jean-Charles Picaud Olivier Claris Mercedes Gil-Campos Ignacio Salamanca De La Cueva Luc Cornette Philippe Alliet André Léké Mireille Castanet Hugues Piloquet Virginie de Halleux Delphine Mitanchez Yvan Vandenplas Pierre Maton Frank Jochum Dirk Olbertz Sergio Negre Policarpo Luca Lavalle Cecilia Fumero Paula Rodriguez-Garcia Janne Marie Moll Irma Silva-Zolezzi Boutaina Zemrani Nicholas P. Hays Norbert Sprenger Javier Miranda-Mallea Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial Frontiers in Nutrition bifidobacteria gastrointestinal tolerance growth gut health microbiota |
| title | Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial |
| title_full | Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial |
| title_fullStr | Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial |
| title_full_unstemmed | Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial |
| title_short | Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial |
| title_sort | partially hydrolyzed whey based infant formula with six human milk oligosaccharides b infantis lmg11588 and b lactis cncm i 3446 is safe well tolerated and improves gut health a staged analysis of a randomized trial |
| topic | bifidobacteria gastrointestinal tolerance growth gut health microbiota |
| url | https://www.frontiersin.org/articles/10.3389/fnut.2025.1628847/full |
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