Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus

Y. Vandenplas, P. Alarcon, D. Fleischer, O. Hernell, S. Kolacek, H. Laignelet, B. Lonnerdal, R. Raman, J. Rigo, S. Salvatore, R. Shamir, A. Staiano, Hania Szajewska, H. J. Van Goudoever, A. von Berg, W. S. Lee

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Partially hydrolyzed formulas (pHFs) are increasingly used worldwide, both in the prevention of atopic disease in at-risk infants and in the therapeutic management of infants with functional gastrointestinal manifestations. Because prevention is always preferable to treatment, we reviewed the literature aiming to find an answer for the question whether pHF may be recommended for feeding all infants if breast-feeding is not possible. PubMed and Cochrane databases were searched up to December 2014. In addition, to search for data that remained undetected by the searches, we approached authors of relevant articles and major producers of pHFs asking for unpublished data. Because few data were found, nonrandomized, controlled trials and trials in preterm infants were included as well. Overall, only limited data could be found on the efficacy and safety of pHF in healthy term infants. Available data do not indicate that pHFs are potentially harmful for healthy, term infants. With respect to long-term outcomes, particularly referring to immune, metabolic and hormonal effects, data are, however, nonexistent. From a regulatory point of view, pHFs meet the nutrient requirements to be considered as standard formula for term healthy infants. Cost, which is different from country to country, should be considered in the decision-making process. Based on limited available data, the use of pHF in healthy infants is safe with regard to growth. The lack of data, in particular for metabolic consequences and long-term outcomes, is, however, the basis for our recommendation that health authorities should develop and support long-term follow-up studies. Efficacy and long-term safety data are required before a recommendation of this type of formula for all infants can be made.
Original languageEnglish
Pages (from-to)22-35
Number of pages14
JournalJournal of Pediatric Gastroenterology and Nutrition
Volume62
DOIs
Publication statusPublished - 2016

Cite this

Vandenplas, Y., Alarcon, P., Fleischer, D., Hernell, O., Kolacek, S., Laignelet, H., ... Lee, W. S. (2016). Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. Journal of Pediatric Gastroenterology and Nutrition, 62, 22-35. https://doi.org/10.1097/mpg.0000000000001014
Vandenplas, Y. ; Alarcon, P. ; Fleischer, D. ; Hernell, O. ; Kolacek, S. ; Laignelet, H. ; Lonnerdal, B. ; Raman, R. ; Rigo, J. ; Salvatore, S. ; Shamir, R. ; Staiano, A. ; Szajewska, Hania ; Van Goudoever, H. J. ; von Berg, A. ; Lee, W. S. / Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. In: Journal of Pediatric Gastroenterology and Nutrition. 2016 ; Vol. 62. pp. 22-35.
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title = "Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus",
abstract = "Partially hydrolyzed formulas (pHFs) are increasingly used worldwide, both in the prevention of atopic disease in at-risk infants and in the therapeutic management of infants with functional gastrointestinal manifestations. Because prevention is always preferable to treatment, we reviewed the literature aiming to find an answer for the question whether pHF may be recommended for feeding all infants if breast-feeding is not possible. PubMed and Cochrane databases were searched up to December 2014. In addition, to search for data that remained undetected by the searches, we approached authors of relevant articles and major producers of pHFs asking for unpublished data. Because few data were found, nonrandomized, controlled trials and trials in preterm infants were included as well. Overall, only limited data could be found on the efficacy and safety of pHF in healthy term infants. Available data do not indicate that pHFs are potentially harmful for healthy, term infants. With respect to long-term outcomes, particularly referring to immune, metabolic and hormonal effects, data are, however, nonexistent. From a regulatory point of view, pHFs meet the nutrient requirements to be considered as standard formula for term healthy infants. Cost, which is different from country to country, should be considered in the decision-making process. Based on limited available data, the use of pHF in healthy infants is safe with regard to growth. The lack of data, in particular for metabolic consequences and long-term outcomes, is, however, the basis for our recommendation that health authorities should develop and support long-term follow-up studies. Efficacy and long-term safety data are required before a recommendation of this type of formula for all infants can be made.",
author = "Y. Vandenplas and P. Alarcon and D. Fleischer and O. Hernell and S. Kolacek and H. Laignelet and B. Lonnerdal and R. Raman and J. Rigo and S. Salvatore and R. Shamir and A. Staiano and Hania Szajewska and {Van Goudoever}, {H. J.} and {von Berg}, A. and Lee, {W. S.}",
note = "M1 - 1 ISI Document Delivery No.: DC5ZV Times Cited: 1 Cited Reference Count: 97 Vandenplas, Yvan Alarcon, Pedro Fleischer, David Hernell, Olle Kolacek, Sanja Laignelet, Hugo Loennerdal, Bo Raman, Rita Rigo, Jacques Salvatore, Silvia Shamir, Raanan Staiano, Annamaria Szajewska, Hania Van Goudoever, Hans J. von Berg, Andrea Lee, Way S. LEE, WAY SEAH/B-8844-2010 LEE, WAY SEAH/0000-0001-9163-2828 Monsanto Company; Nestle Nutrition Institute Y.V. has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Abbott Nutrition, ASPEN, Biogaia, Biocodex, Danone, Dumex, Hero, Hipp, Nestle Nutrition Institute, Nutricia, Mead Johnson, Merck, Menarini, Orafti, Pfizer, Phacobel, Sari Husada, Shire (Movetis), Sucampo, Takeda, United Pharmaceuticals, Wyeth, and Yakult. P.A. is a former Abbott Nutrition's International Medical Director. Has participated as advisory board member for Sanofi Pasteur. D.F. received grant support from Monsanto Company, Nestle Nutrition Institute. D.F. is also at speaker's bureau for Nestle Nutrition Institute; advisory boards for Food Allergy & Anaphylaxis Connection Team, Food Allergy Research & Education. D.F. is a consultant for Receptos; LabCorp. O.H. has participated as a clinical investigator, or advisory board member, or consultant or speaker for Swedish Orphan Biovitrum (Sobii), Mead Johnson Nutrition, Arla Foods, Hero, Semper, Hipp, and Valio. S.K. has participated as a clinical investigator and/or lecturer for Abbott Nutrition, Abbvie, Biogaia, Chr. Hansen, Danone, Dukat, Fresenius, GM Pharma, MSD, Nestle, Nestle Nutrition Institute, and Podravka. H.L. has participated as a clinical investigator or advisory board member or speaker for Sanofi, Abbott Nutrition, Nutricia, Aztra, Mead Johnson, Nestle, and Procaps. B.L. has participated as a clinical investigator, or advisory board member, or consultant or speaker for Mead Johnson Nutrition, Arla Foods, Hero, Albion, Valio, Humana, Biostime, Nestle, and Nestle Nutrition Institute. R.R. has participated as a Speaker for Abbott Nutrition. J.R. has participate as a clinical investigator or advisory board member or speaker for Mead Jonhson Nutrition, Danone, Nestle, and Nutricia. S.S. has participated as a consultant and/or speaker for Arla Foods, Danone/Nutricia, IMS Health, Menarini, Milte, Nestle Nutrition Institute. R.S. has participated as a clinical investigator, or advisory board member, or consultant or speaker for Abbott, Danone, Enzymotec, Ferrero, Nestle Nutrition Institute, Nutricia, and Teva. A.S. has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for D.M.G, Valeas, Angelini, Milte, Danone, Nestle, Sucampo, Menarini. H.S. has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Arla, Biogaia, Biocodex, Danone, Dicofarm, Hipp, Nestle, Nestle Nutrition Institute, Nutricia, Mead Johnson, Merck, and Sequoia. H.J.v.G. is member of the National Breastfeeding Board, National Health Council and is founder and director of the Dutch Human Milk Bank. He has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Ajinomoto, Biogaia, Dumex, Danone, Enzymotec, Ferrero, Hipp, Kabi/Fresenius, Nestle Nutrition Institute, Nutricia, Mead Johnson. A.v.B. has participated as a clinical investigator, and/or speaker for Nestle, Nestle Nutrition Institute, Nutricia, Mead Johnson. W.S.L. has participated as a clinical investigator and/or speaker for Danone Nutrition, Abbott Nutrition, Mead Johnson, Nestle Nutrition Institute. 1 4 16 LIPPINCOTT WILLIAMS & WILKINS PHILADELPHIA J PEDIATR GASTR NUTR",
year = "2016",
doi = "10.1097/mpg.0000000000001014",
language = "English",
volume = "62",
pages = "22--35",
journal = "Journal of Pediatric Gastroenterology and Nutrition",
issn = "0277-2116",
publisher = "Lippincott Williams and Wilkins",

}

Vandenplas, Y, Alarcon, P, Fleischer, D, Hernell, O, Kolacek, S, Laignelet, H, Lonnerdal, B, Raman, R, Rigo, J, Salvatore, S, Shamir, R, Staiano, A, Szajewska, H, Van Goudoever, HJ, von Berg, A & Lee, WS 2016, 'Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus' Journal of Pediatric Gastroenterology and Nutrition, vol. 62, pp. 22-35. https://doi.org/10.1097/mpg.0000000000001014

Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. / Vandenplas, Y.; Alarcon, P.; Fleischer, D.; Hernell, O.; Kolacek, S.; Laignelet, H.; Lonnerdal, B.; Raman, R.; Rigo, J.; Salvatore, S.; Shamir, R.; Staiano, A.; Szajewska, Hania; Van Goudoever, H. J.; von Berg, A.; Lee, W. S.

In: Journal of Pediatric Gastroenterology and Nutrition, Vol. 62, 2016, p. 22-35.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus

AU - Vandenplas, Y.

AU - Alarcon, P.

AU - Fleischer, D.

AU - Hernell, O.

AU - Kolacek, S.

AU - Laignelet, H.

AU - Lonnerdal, B.

AU - Raman, R.

AU - Rigo, J.

AU - Salvatore, S.

AU - Shamir, R.

AU - Staiano, A.

AU - Szajewska, Hania

AU - Van Goudoever, H. J.

AU - von Berg, A.

AU - Lee, W. S.

N1 - M1 - 1 ISI Document Delivery No.: DC5ZV Times Cited: 1 Cited Reference Count: 97 Vandenplas, Yvan Alarcon, Pedro Fleischer, David Hernell, Olle Kolacek, Sanja Laignelet, Hugo Loennerdal, Bo Raman, Rita Rigo, Jacques Salvatore, Silvia Shamir, Raanan Staiano, Annamaria Szajewska, Hania Van Goudoever, Hans J. von Berg, Andrea Lee, Way S. LEE, WAY SEAH/B-8844-2010 LEE, WAY SEAH/0000-0001-9163-2828 Monsanto Company; Nestle Nutrition Institute Y.V. has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Abbott Nutrition, ASPEN, Biogaia, Biocodex, Danone, Dumex, Hero, Hipp, Nestle Nutrition Institute, Nutricia, Mead Johnson, Merck, Menarini, Orafti, Pfizer, Phacobel, Sari Husada, Shire (Movetis), Sucampo, Takeda, United Pharmaceuticals, Wyeth, and Yakult. P.A. is a former Abbott Nutrition's International Medical Director. Has participated as advisory board member for Sanofi Pasteur. D.F. received grant support from Monsanto Company, Nestle Nutrition Institute. D.F. is also at speaker's bureau for Nestle Nutrition Institute; advisory boards for Food Allergy & Anaphylaxis Connection Team, Food Allergy Research & Education. D.F. is a consultant for Receptos; LabCorp. O.H. has participated as a clinical investigator, or advisory board member, or consultant or speaker for Swedish Orphan Biovitrum (Sobii), Mead Johnson Nutrition, Arla Foods, Hero, Semper, Hipp, and Valio. S.K. has participated as a clinical investigator and/or lecturer for Abbott Nutrition, Abbvie, Biogaia, Chr. Hansen, Danone, Dukat, Fresenius, GM Pharma, MSD, Nestle, Nestle Nutrition Institute, and Podravka. H.L. has participated as a clinical investigator or advisory board member or speaker for Sanofi, Abbott Nutrition, Nutricia, Aztra, Mead Johnson, Nestle, and Procaps. B.L. has participated as a clinical investigator, or advisory board member, or consultant or speaker for Mead Johnson Nutrition, Arla Foods, Hero, Albion, Valio, Humana, Biostime, Nestle, and Nestle Nutrition Institute. R.R. has participated as a Speaker for Abbott Nutrition. J.R. has participate as a clinical investigator or advisory board member or speaker for Mead Jonhson Nutrition, Danone, Nestle, and Nutricia. S.S. has participated as a consultant and/or speaker for Arla Foods, Danone/Nutricia, IMS Health, Menarini, Milte, Nestle Nutrition Institute. R.S. has participated as a clinical investigator, or advisory board member, or consultant or speaker for Abbott, Danone, Enzymotec, Ferrero, Nestle Nutrition Institute, Nutricia, and Teva. A.S. has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for D.M.G, Valeas, Angelini, Milte, Danone, Nestle, Sucampo, Menarini. H.S. has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Arla, Biogaia, Biocodex, Danone, Dicofarm, Hipp, Nestle, Nestle Nutrition Institute, Nutricia, Mead Johnson, Merck, and Sequoia. H.J.v.G. is member of the National Breastfeeding Board, National Health Council and is founder and director of the Dutch Human Milk Bank. He has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Ajinomoto, Biogaia, Dumex, Danone, Enzymotec, Ferrero, Hipp, Kabi/Fresenius, Nestle Nutrition Institute, Nutricia, Mead Johnson. A.v.B. has participated as a clinical investigator, and/or speaker for Nestle, Nestle Nutrition Institute, Nutricia, Mead Johnson. W.S.L. has participated as a clinical investigator and/or speaker for Danone Nutrition, Abbott Nutrition, Mead Johnson, Nestle Nutrition Institute. 1 4 16 LIPPINCOTT WILLIAMS & WILKINS PHILADELPHIA J PEDIATR GASTR NUTR

PY - 2016

Y1 - 2016

N2 - Partially hydrolyzed formulas (pHFs) are increasingly used worldwide, both in the prevention of atopic disease in at-risk infants and in the therapeutic management of infants with functional gastrointestinal manifestations. Because prevention is always preferable to treatment, we reviewed the literature aiming to find an answer for the question whether pHF may be recommended for feeding all infants if breast-feeding is not possible. PubMed and Cochrane databases were searched up to December 2014. In addition, to search for data that remained undetected by the searches, we approached authors of relevant articles and major producers of pHFs asking for unpublished data. Because few data were found, nonrandomized, controlled trials and trials in preterm infants were included as well. Overall, only limited data could be found on the efficacy and safety of pHF in healthy term infants. Available data do not indicate that pHFs are potentially harmful for healthy, term infants. With respect to long-term outcomes, particularly referring to immune, metabolic and hormonal effects, data are, however, nonexistent. From a regulatory point of view, pHFs meet the nutrient requirements to be considered as standard formula for term healthy infants. Cost, which is different from country to country, should be considered in the decision-making process. Based on limited available data, the use of pHF in healthy infants is safe with regard to growth. The lack of data, in particular for metabolic consequences and long-term outcomes, is, however, the basis for our recommendation that health authorities should develop and support long-term follow-up studies. Efficacy and long-term safety data are required before a recommendation of this type of formula for all infants can be made.

AB - Partially hydrolyzed formulas (pHFs) are increasingly used worldwide, both in the prevention of atopic disease in at-risk infants and in the therapeutic management of infants with functional gastrointestinal manifestations. Because prevention is always preferable to treatment, we reviewed the literature aiming to find an answer for the question whether pHF may be recommended for feeding all infants if breast-feeding is not possible. PubMed and Cochrane databases were searched up to December 2014. In addition, to search for data that remained undetected by the searches, we approached authors of relevant articles and major producers of pHFs asking for unpublished data. Because few data were found, nonrandomized, controlled trials and trials in preterm infants were included as well. Overall, only limited data could be found on the efficacy and safety of pHF in healthy term infants. Available data do not indicate that pHFs are potentially harmful for healthy, term infants. With respect to long-term outcomes, particularly referring to immune, metabolic and hormonal effects, data are, however, nonexistent. From a regulatory point of view, pHFs meet the nutrient requirements to be considered as standard formula for term healthy infants. Cost, which is different from country to country, should be considered in the decision-making process. Based on limited available data, the use of pHF in healthy infants is safe with regard to growth. The lack of data, in particular for metabolic consequences and long-term outcomes, is, however, the basis for our recommendation that health authorities should develop and support long-term follow-up studies. Efficacy and long-term safety data are required before a recommendation of this type of formula for all infants can be made.

U2 - 10.1097/mpg.0000000000001014

DO - 10.1097/mpg.0000000000001014

M3 - Article

VL - 62

SP - 22

EP - 35

JO - Journal of Pediatric Gastroenterology and Nutrition

JF - Journal of Pediatric Gastroenterology and Nutrition

SN - 0277-2116

ER -