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Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial
This randomized clinical trial (Registration: NCT03085134) assessed if an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) and reduced protein content (2.20 g/100 kcal) supports normal growth in infants with cow’s milk protein allergy (CMPA). Secondary out...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8839689/ https://www.ncbi.nlm.nih.gov/pubmed/35276889 http://dx.doi.org/10.3390/nu14030530 |
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author | Vandenplas, Yvan Żołnowska, Marta Berni Canani, Roberto Ludman, Siân Tengelyi, Zsuzsanna Moreno-Álvarez, Ana Goh, Anne E. N. Gosoniu, Maria Laura Kirwan, Bridget-Anne Tadi, Monika Heine, Ralf G. |
author_facet | Vandenplas, Yvan Żołnowska, Marta Berni Canani, Roberto Ludman, Siân Tengelyi, Zsuzsanna Moreno-Álvarez, Ana Goh, Anne E. N. Gosoniu, Maria Laura Kirwan, Bridget-Anne Tadi, Monika Heine, Ralf G. |
author_sort | Vandenplas, Yvan |
collection | PubMed |
description | This randomized clinical trial (Registration: NCT03085134) assessed if an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) and reduced protein content (2.20 g/100 kcal) supports normal growth in infants with cow’s milk protein allergy (CMPA). Secondary outcomes were gastrointestinal tolerability, safety, and effect on infections. Nonbreastfed infants aged 0–6 months with CMPA were enrolled. Body weight, length, and head circumference were measured monthly for 4 months (primary study endpoint), after 6 months, and at the age of 12 months. Of 200 infants screened, 194 (mean age 3.2 months) were randomized. At the 4-month follow-up, daily weight gain for the test formula was noninferior to the control formula; p < 0.005. There were no significant group differences in anthropometric parameters. Both formulas were safe and well tolerated. Infants in the HMO group had a statistically significant reduction in the frequency of upper respiratory tract infections and a lower incidence of ear infections at 12 months (per protocol analysis). The relative risk of lower respiratory tract and gastrointestinal infections was reduced by 30–40%, but this was not statistically significant due to sample size limitations. In summary, the HMO-supplemented formula supports normal growth in infants with CMPA and suggests a protective effect against respiratory and ear infections in the first year of life. |
format | Online Article Text |
id | pubmed-8839689 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-88396892022-02-13 Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial Vandenplas, Yvan Żołnowska, Marta Berni Canani, Roberto Ludman, Siân Tengelyi, Zsuzsanna Moreno-Álvarez, Ana Goh, Anne E. N. Gosoniu, Maria Laura Kirwan, Bridget-Anne Tadi, Monika Heine, Ralf G. Nutrients Article This randomized clinical trial (Registration: NCT03085134) assessed if an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) and reduced protein content (2.20 g/100 kcal) supports normal growth in infants with cow’s milk protein allergy (CMPA). Secondary outcomes were gastrointestinal tolerability, safety, and effect on infections. Nonbreastfed infants aged 0–6 months with CMPA were enrolled. Body weight, length, and head circumference were measured monthly for 4 months (primary study endpoint), after 6 months, and at the age of 12 months. Of 200 infants screened, 194 (mean age 3.2 months) were randomized. At the 4-month follow-up, daily weight gain for the test formula was noninferior to the control formula; p < 0.005. There were no significant group differences in anthropometric parameters. Both formulas were safe and well tolerated. Infants in the HMO group had a statistically significant reduction in the frequency of upper respiratory tract infections and a lower incidence of ear infections at 12 months (per protocol analysis). The relative risk of lower respiratory tract and gastrointestinal infections was reduced by 30–40%, but this was not statistically significant due to sample size limitations. In summary, the HMO-supplemented formula supports normal growth in infants with CMPA and suggests a protective effect against respiratory and ear infections in the first year of life. MDPI 2022-01-26 /pmc/articles/PMC8839689/ /pubmed/35276889 http://dx.doi.org/10.3390/nu14030530 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Vandenplas, Yvan Żołnowska, Marta Berni Canani, Roberto Ludman, Siân Tengelyi, Zsuzsanna Moreno-Álvarez, Ana Goh, Anne E. N. Gosoniu, Maria Laura Kirwan, Bridget-Anne Tadi, Monika Heine, Ralf G. Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial |
title | Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial |
title_full | Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial |
title_fullStr | Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial |
title_full_unstemmed | Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial |
title_short | Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow’s Milk Protein Allergy: A Randomized, Multi-Center Trial |
title_sort | effects of an extensively hydrolyzed formula supplemented with two human milk oligosaccharides on growth, tolerability, safety and infection risk in infants with cow’s milk protein allergy: a randomized, multi-center trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8839689/ https://www.ncbi.nlm.nih.gov/pubmed/35276889 http://dx.doi.org/10.3390/nu14030530 |
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