Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI

Chris H P van den Akker^{1

2}, Nicholas D Embleton³, Alexandre Lapillonne^{4

5}, Walter A Mihatsch^{6

7

8}, Silva Salvatore⁹, Roberto B Canani¹⁰, Ener C Dinleyici¹¹, Magnus Domellöf¹², Alfredo Guarino¹³, Pedro Gutiérrez-Castrellón¹⁴, Iva Hojsak¹⁵, Flavia Indrio¹⁶, Alexis Mosca¹⁷, Rok Orel¹⁸, Johannes Hans B van Goudoever¹⁹, Zvi Weizman²⁰, Silke Mader²¹, Luc J I Zimmermann^{21

22}, Raanan Shamir²³, Yvan Vandenplas²⁴, Hania Szajewska²⁵

Affiliations

¹ Department of Pediatrics-Neonatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
² Amsterdam Reproduction and Development, and Amsterdam Gastroenterology Endocrinology Metabolism Research Institutes, Amsterdam, The Netherlands.
³ Neonatal Unit, Royal Victoria Infirmary, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
⁴ Department of Neonatology, APHP Necker University Hospital, Paris Cite University, Paris, France.
⁵ Department of Pediatrics, Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas, USA.
⁶ Department of Pediatrics, Ulm University, Ulm, Germany.
⁷ Department of Health Management, Neu-Ulm University of Applied Sciences, Neu-Ulm, Germany.
⁸ Department of Pediatrics, Zollernalb Klinikum, Balingen, Germany.
⁹ Department of Medicine and Technological Innovation, Pediatrics, Hospital "F. Del Ponte", University of Insubria, Varese, Italy.
¹⁰ Department of Translational Medical Science and the ImmunoNutritionLab at the Ceinge Research Center and Task Force on Microbiome Studies, University of Naples Federico II, Naples, Italy.
¹¹ Department of Pediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey.
¹² Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
¹³ Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy.
¹⁴ International Scientific Council for Probiotics, A.C., Ciudad de México (CDMX), Mexico.
¹⁵ Department of Pediatrics, University of Zagreb Medical School, Children's Hospital Zagreb, Zagreb, Croatia.
¹⁶ Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, Lecce, Italy.
¹⁷ Department Pediatric Gastroenterology and Nutrition, Robert-Debré Hospital, APHP, Paris, France.
¹⁸ Department of Gastroenterology, Hepatology and Nutrition, University Medical Center Ljubljana, University Children's Hospital Ljubljana, Medical Faculty, University of Ljubljana, Ljubeljana, Slovenia.
¹⁹ Department of Pediatrics, Amsterdam UMC, Emma Children's Hospital, University of Amsterdam, Amsterdam, The Netherlands.
²⁰ Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel.
²¹ European Foundation for the Care of Newborn Infants (EFCNI), Munich, Germany.
²² Department of Pediatrics, School for Oncology and Reproduction (GROW), Maastricht UMC+, Maastricht, The Netherlands.
²³ Institute for Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
²⁴ Department of Pediatrics, UZ Brussel, KidZ Health Castle, Vrije Universiteit Brussel (VUB), Brussels, Belgium.
²⁵ Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland.

PMID: 38572770
DOI: 10.1002/jpn3.12204

Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI

Chris H P van den Akker et al. J Pediatr Gastroenterol Nutr. 2024 Jun.

. 2024 Jun;78(6):1403-1408.

doi: 10.1002/jpn3.12204. Epub 2024 Apr 4.

Authors

Affiliations

¹ Department of Pediatrics-Neonatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
² Amsterdam Reproduction and Development, and Amsterdam Gastroenterology Endocrinology Metabolism Research Institutes, Amsterdam, The Netherlands.
³ Neonatal Unit, Royal Victoria Infirmary, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
⁴ Department of Neonatology, APHP Necker University Hospital, Paris Cite University, Paris, France.
⁵ Department of Pediatrics, Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas, USA.
⁶ Department of Pediatrics, Ulm University, Ulm, Germany.
⁷ Department of Health Management, Neu-Ulm University of Applied Sciences, Neu-Ulm, Germany.
⁸ Department of Pediatrics, Zollernalb Klinikum, Balingen, Germany.
⁹ Department of Medicine and Technological Innovation, Pediatrics, Hospital "F. Del Ponte", University of Insubria, Varese, Italy.
¹⁰ Department of Translational Medical Science and the ImmunoNutritionLab at the Ceinge Research Center and Task Force on Microbiome Studies, University of Naples Federico II, Naples, Italy.
¹¹ Department of Pediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey.
¹² Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
¹³ Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy.
¹⁴ International Scientific Council for Probiotics, A.C., Ciudad de México (CDMX), Mexico.
¹⁵ Department of Pediatrics, University of Zagreb Medical School, Children's Hospital Zagreb, Zagreb, Croatia.
¹⁶ Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, Lecce, Italy.
¹⁷ Department Pediatric Gastroenterology and Nutrition, Robert-Debré Hospital, APHP, Paris, France.
¹⁸ Department of Gastroenterology, Hepatology and Nutrition, University Medical Center Ljubljana, University Children's Hospital Ljubljana, Medical Faculty, University of Ljubljana, Ljubeljana, Slovenia.
¹⁹ Department of Pediatrics, Amsterdam UMC, Emma Children's Hospital, University of Amsterdam, Amsterdam, The Netherlands.
²⁰ Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel.
²¹ European Foundation for the Care of Newborn Infants (EFCNI), Munich, Germany.
²² Department of Pediatrics, School for Oncology and Reproduction (GROW), Maastricht UMC+, Maastricht, The Netherlands.
²³ Institute for Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
²⁴ Department of Pediatrics, UZ Brussel, KidZ Health Castle, Vrije Universiteit Brussel (VUB), Brussels, Belgium.
²⁵ Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland.

PMID: 38572770
DOI: 10.1002/jpn3.12204

Abstract

The recent advisory issued by the United States Food and Drug Administration, cautioning against the routine administration of probiotics in preterm neonates, has sparked a lively debate within the scientific community. This commentary presents a perspective from members of the Special Interest Group on Gut Microbiota and Modifications within the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and other authors who contributed to the ESPGHAN position paper on probiotics for preterm infants, as well as representatives from the European Foundation for the Care of Newborn Infants. We advocate for a more nuanced and supportive approach to the use of certain probiotics in this vulnerable population, balancing the demonstrated benefits and risks.

Keywords: live biotherapeutic product; necrotizing enterocolitis; premature infants; probiotic drug; probiotic sepsis.

© 2024 The Authors. Journal of Pediatric Gastroenterology and Nutrition published by Wiley Periodicals LLC on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

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References

REFERENCES

1. U.S. Food and Drug Administration. Safety and availability communication and press anouncement. 2023. Accessed October 27, 2023. https://www.fda.gov/media/172606/download?attachment
1. https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-...
1. International Scientific Association for Probiotics and Prebiotics. Probiotic administration in preterm infants: scientific statement. 2023. Accessed October 27, 2023. https://isappscience.org/probiotic-administration-in-preterm-infants-sci...
1. Barrington K. Neonatal research blog: probiotics. What now? October 6, 2023. Accessed October 27, 2023. https://neonatalresearch.org/2023/10/06/probiotics-what-now/
1. Embleton ND, Berrington J, Clarke P, et al. Probiotics for preterm infants and the recent FDA alert in the USA. Arch Dis Child Fetal Neonatal Ed. 2023. Published online December 16, 2023. https://doi.org/10.1136/archdischild-2023-326580

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Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI

Affiliations

Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI

Authors

Affiliations

Abstract

References

REFERENCES

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical