1. 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
- Author
-
Yvan, Vandenplas, Marta, Żołnowska, Roberto, Berni Canani, Siân, Ludman, Zsuzsanna, Tengelyi, Ana, Moreno-Álvarez, Anne E N, Goh, Maria Laura, Gosoniu, Bridget-Anne, Kirwan, Monika, Tadi, Ralf G, Heine, Cinnamon Study Investigator Group, Vandenplas, Y., Zolnowska, M., Canani, R. B., Ludman, S., Tengelyi, Z., Moreno-alvarez, A., Goh, A. E. N., Gosoniu, M. L., Kirwan, B. -A., Tadi, M., Heine, R. G., Clinical sciences, Growth and Development, and Pediatrics
- Subjects
Milk Hypersensitivity/etiology ,Lacto-N-neotetraose ,′ ,Whey hydrolysate ,Oligosaccharides ,fucosyllactose ,Respiratory infec-tion ,respiratory infection ,Food allergy ,Animals ,TX341-641 ,Pediatrics, Perinatology, and Child Health ,Otitis media ,Nutrition and Dietetics ,Gastroenteriti ,Milk, Human ,Nutrition. Foods and food supply ,Body Weight ,Oligosaccharides/adverse effects ,2′-fucosyllactose ,lacto-N-neotetraose ,food allergy ,whey hydrolysate ,otitis media ,gastroenteritis ,Dietary Supplements ,Cattle ,Female ,Milk Hypersensitivity ,Food Science - Abstract
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.
- Published
- 2021