Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy
This open-label, non-randomized, multicenter trial (Registration: NCT 03661736) aimed to assess if an amino acid-based formula (AAF) supplemented with two human milk oligosaccharides (HMO) supports normal growth and is well tolerated in infants with a cow’s milk protein allergy (CMPA). Term infants...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-05-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/14/11/2297 |
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| author | Michael S. Gold Patrick J. Quinn Dianne E. Campbell Jane Peake Joanne Smart Marnie Robinson Michael O’Sullivan Josef Korbinian Vogt Helle Krogh Pedersen Xiaoqiu Liu Elham Pazirandeh-Micol Ralf G. Heine |
| author_facet | Michael S. Gold Patrick J. Quinn Dianne E. Campbell Jane Peake Joanne Smart Marnie Robinson Michael O’Sullivan Josef Korbinian Vogt Helle Krogh Pedersen Xiaoqiu Liu Elham Pazirandeh-Micol Ralf G. Heine |
| author_sort | Michael S. Gold |
| collection | DOAJ |
| description | This open-label, non-randomized, multicenter trial (Registration: NCT 03661736) aimed to assess if an amino acid-based formula (AAF) supplemented with two human milk oligosaccharides (HMO) supports normal growth and is well tolerated in infants with a cow’s milk protein allergy (CMPA). Term infants aged 1–8 months with moderate-to-severe CMPA were enrolled. The study formula was an AAF supplemented with 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT). Infants were fed the study formula for 4 months and were offered to remain on the formula until 12 months of age. Tolerance and safety were assessed throughout the trial. Out of 32 infants (mean age 18.6 weeks; 20 (62.5%) male), 29 completed the trial. During the 4-month principal study period, the mean weight-for-age Z score (WAZ) increased from −0.31 at the baseline to +0.28 at the 4-months’ follow-up. Linear and head growth also progressed along the WHO child growth reference, with a similar small upward trend. The formula was well tolerated and had an excellent safety profile. When comparing the microbiome at the baseline to the subsequent visits, there was a significant on-treatment enrichment in HMO-utilizing bifidobacteria, which was associated with a significant increase in fecal short-chain fatty acids. In addition, we observed a significant reduction in the abundance of fecal Proteobacteria, suggesting that the HMO-supplemented study formula partially corrected the gut microbial dysbiosis in infants with CMPA. |
| first_indexed | 2024-03-10T00:59:40Z |
| format | Article |
| id | doaj.art-6b1b52164ef94a498c7b3289ebba4a9b |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-10T00:59:40Z |
| publishDate | 2022-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-6b1b52164ef94a498c7b3289ebba4a9b2023-11-23T14:36:49ZengMDPI AGNutrients2072-66432022-05-011411229710.3390/nu14112297Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein AllergyMichael S. Gold0Patrick J. Quinn1Dianne E. Campbell2Jane Peake3Joanne Smart4Marnie Robinson5Michael O’Sullivan6Josef Korbinian Vogt7Helle Krogh Pedersen8Xiaoqiu Liu9Elham Pazirandeh-Micol10Ralf G. Heine11Department of Allergy & Immunology, Women’s and Children’s Hospital, University of Adelaide, Adelaide, SA 5006, AustraliaDepartment of Allergy & Immunology, Women’s and Children’s Hospital, University of Adelaide, Adelaide, SA 5006, AustraliaDepartment of Allergy & Clinical Immunology, Children’s Hospital at Westmead, University of Sydney, Sydney, NSW 2145, AustraliaQueensland Paediatric Immunology and Allergy Service, Queensland Children’s Hospital, University of Queensland, South Brisbane, QLD 4101, AustraliaPaediatric Allergy Services, Epworth Hospital, Richmond, VIC 3121, AustraliaMelbourne Allergy Centre & Children’s Specialists Medical Group, Parkville, VIC 3152, AustraliaDepartment of Immunology, Perth Children’s Hospital, Nedlands, WA 6009, AustraliaClinical Microbiomics, DK-2100 Copenhagen, DenmarkClinical Microbiomics, DK-2100 Copenhagen, DenmarkBiostatistics and Data Science Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW 2042, AustraliaNestlé Health Science, CH-1800 Vevey, SwitzerlandNestlé Health Science, CH-1800 Vevey, SwitzerlandThis open-label, non-randomized, multicenter trial (Registration: NCT 03661736) aimed to assess if an amino acid-based formula (AAF) supplemented with two human milk oligosaccharides (HMO) supports normal growth and is well tolerated in infants with a cow’s milk protein allergy (CMPA). Term infants aged 1–8 months with moderate-to-severe CMPA were enrolled. The study formula was an AAF supplemented with 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT). Infants were fed the study formula for 4 months and were offered to remain on the formula until 12 months of age. Tolerance and safety were assessed throughout the trial. Out of 32 infants (mean age 18.6 weeks; 20 (62.5%) male), 29 completed the trial. During the 4-month principal study period, the mean weight-for-age Z score (WAZ) increased from −0.31 at the baseline to +0.28 at the 4-months’ follow-up. Linear and head growth also progressed along the WHO child growth reference, with a similar small upward trend. The formula was well tolerated and had an excellent safety profile. When comparing the microbiome at the baseline to the subsequent visits, there was a significant on-treatment enrichment in HMO-utilizing bifidobacteria, which was associated with a significant increase in fecal short-chain fatty acids. In addition, we observed a significant reduction in the abundance of fecal Proteobacteria, suggesting that the HMO-supplemented study formula partially corrected the gut microbial dysbiosis in infants with CMPA.https://www.mdpi.com/2072-6643/14/11/22972′-fucosyllactoselacto-N-neotetraosehypoallergenic formulagut microbiomemetagenomic sequencingbifidobacteria |
| spellingShingle | Michael S. Gold Patrick J. Quinn Dianne E. Campbell Jane Peake Joanne Smart Marnie Robinson Michael O’Sullivan Josef Korbinian Vogt Helle Krogh Pedersen Xiaoqiu Liu Elham Pazirandeh-Micol Ralf G. Heine Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy Nutrients 2′-fucosyllactose lacto-N-neotetraose hypoallergenic formula gut microbiome metagenomic sequencing bifidobacteria |
| title | Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy |
| title_full | Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy |
| title_fullStr | Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy |
| title_full_unstemmed | Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy |
| title_short | Effects of an Amino Acid-Based Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety, and Gut Microbiome in Infants with Cow’s Milk Protein Allergy |
| title_sort | effects of an amino acid based formula supplemented with two human milk oligosaccharides on growth tolerability safety and gut microbiome in infants with cow s milk protein allergy |
| topic | 2′-fucosyllactose lacto-N-neotetraose hypoallergenic formula gut microbiome metagenomic sequencing bifidobacteria |
| url | https://www.mdpi.com/2072-6643/14/11/2297 |
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