| Autor: |
Gold MS; Department of Allergy & Immunology, Women's and Children's Hospital, University of Adelaide, Adelaide, SA 5006, Australia., Quinn PJ; Department of Allergy & Immunology, Women's and Children's Hospital, University of Adelaide, Adelaide, SA 5006, Australia., Campbell DE; Department of Allergy & Clinical Immunology, Children's Hospital at Westmead, University of Sydney, Sydney, NSW 2145, Australia., Peake J; Queensland Paediatric Immunology and Allergy Service, Queensland Children's Hospital, University of Queensland, South Brisbane, QLD 4101, Australia., Smart J; Paediatric Allergy Services, Epworth Hospital, Richmond, VIC 3121, Australia., Robinson M; Melbourne Allergy Centre & Children's Specialists Medical Group, Parkville, VIC 3152, Australia., O'Sullivan M; Department of Immunology, Perth Children's Hospital, Nedlands, WA 6009, Australia., Vogt JK; Clinical Microbiomics, DK-2100 Copenhagen, Denmark., Pedersen HK; Clinical Microbiomics, DK-2100 Copenhagen, Denmark., Liu X; Biostatistics and Data Science Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW 2042, Australia., Pazirandeh-Micol E; Nestlé Health Science, CH-1800 Vevey, Switzerland., Heine RG; Nestlé Health Science, CH-1800 Vevey, Switzerland. |
| Abstrakt: |
This open-label, non-randomized, multicenter trial (Registration: NCT03661736) 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. |
