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Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants.
Pediatr Allergy Immunol. 2015 Jun; 26(4):316-22.PA

Abstract

BACKGROUND

Children with cow's milk allergy (CMA) are at risk for inadequate nutritional intake and growth. Dietary management of CMA, therefore, requires diets that are not only hypoallergenic but also support adequate growth in this population. This study assessed growth of CMA infants when using a new amino acid-based formula (AAF) with prebiotics and probiotics (synbiotics) and evaluated its safety in the intended population.

METHODS

In a prospective, randomized, double-blind controlled study, full-term infants with diagnosed CMA received either an AAF (control; n = 56) or AAF with synbiotics (oligofructose, long-chain inulin, acidic oligosaccharides, Bifidobacterium breve M-16V) (test; n = 54) for 16 wk. Primary outcome was growth, measured as weight, length and head circumference. Secondary outcomes included allergic symptoms and stool characteristics.

RESULTS

Average age (±SD) of infants at inclusion was 4.5 ± 2.4 months. Both formulas equally supported growth according to WHO 2006 growth charts and resulted in similar increases of weight, length and head circumference. At week 16, differences (90% CI) in Z-scores (test-control) were as follows: weight 0.147 (-0.10; 0.39, p = 0.32), length -0.299 (-0.69; 0.09, p = 0.21) and head circumference 0.152 (-0.15; 0.45, p = 0.40). Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups. Both formulas were well tolerated and reduced allergic symptoms; the number of adverse events was not different between the groups.

CONCLUSIONS

This is the first study that shows that an AAF with a specific synbiotic blend, suitable for CMA infants, supports normal growth and growth similar to the AAF without synbiotics. This clinical trial is registered as NCT00664768.

Authors+Show Affiliations

University of North Carolina, Chapel Hill, NC, USA.Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands. Nutricia Advanced Medical Nutrition, Liverpool, UK.Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.Nutricia Advanced Medical Nutrition, Liverpool, UK.Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands. Laboratory of Microbiology, Wageningen University, Wageningen, The Netherlands.Visions Clinical Research, Tucson, AZ, USA.Children's Hospital Los Angeles/University of Southern California, Los Angeles, CA, USA.Meridian Clinical Research, Omaha, NE, USA.Asheboro Research Associates, Asheboro, NC, USA.Children's Investigational Research Program, LLC (CHIRP), Bentonville, AR, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

25845680

Citation

Burks, A Wesley, et al. "Synbiotics-supplemented Amino Acid-based Formula Supports Adequate Growth in Cow's Milk Allergic Infants." Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, vol. 26, no. 4, 2015, pp. 316-22.
Burks AW, Harthoorn LF, Van Ampting MT, et al. Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants. Pediatr Allergy Immunol. 2015;26(4):316-22.
Burks, A. W., Harthoorn, L. F., Van Ampting, M. T., Oude Nijhuis, M. M., Langford, J. E., Wopereis, H., Goldberg, S. B., Ong, P. Y., Essink, B. J., Scott, R. B., & Harvey, B. M. (2015). Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants. Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, 26(4), 316-22. https://doi.org/10.1111/pai.12390
Burks AW, et al. Synbiotics-supplemented Amino Acid-based Formula Supports Adequate Growth in Cow's Milk Allergic Infants. Pediatr Allergy Immunol. 2015;26(4):316-22. PubMed PMID: 25845680.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants. AU - Burks,A Wesley, AU - Harthoorn,Lucien F, AU - Van Ampting,Marleen T J, AU - Oude Nijhuis,Manon M, AU - Langford,Jane E, AU - Wopereis,Harm, AU - Goldberg,Steven B, AU - Ong,Peck Y, AU - Essink,Brandon J, AU - Scott,Robert B, AU - Harvey,Bryan M, PY - 2015/03/31/accepted PY - 2015/4/8/entrez PY - 2015/4/8/pubmed PY - 2016/4/14/medline KW - amino acid-based formula KW - cow's milk allergy KW - growth KW - infant KW - prebiotics KW - probiotics KW - randomized double-blind controlled trial KW - safety SP - 316 EP - 22 JF - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology JO - Pediatr Allergy Immunol VL - 26 IS - 4 N2 - BACKGROUND: Children with cow's milk allergy (CMA) are at risk for inadequate nutritional intake and growth. Dietary management of CMA, therefore, requires diets that are not only hypoallergenic but also support adequate growth in this population. This study assessed growth of CMA infants when using a new amino acid-based formula (AAF) with prebiotics and probiotics (synbiotics) and evaluated its safety in the intended population. METHODS: In a prospective, randomized, double-blind controlled study, full-term infants with diagnosed CMA received either an AAF (control; n = 56) or AAF with synbiotics (oligofructose, long-chain inulin, acidic oligosaccharides, Bifidobacterium breve M-16V) (test; n = 54) for 16 wk. Primary outcome was growth, measured as weight, length and head circumference. Secondary outcomes included allergic symptoms and stool characteristics. RESULTS: Average age (±SD) of infants at inclusion was 4.5 ± 2.4 months. Both formulas equally supported growth according to WHO 2006 growth charts and resulted in similar increases of weight, length and head circumference. At week 16, differences (90% CI) in Z-scores (test-control) were as follows: weight 0.147 (-0.10; 0.39, p = 0.32), length -0.299 (-0.69; 0.09, p = 0.21) and head circumference 0.152 (-0.15; 0.45, p = 0.40). Weight-for-age and length-for-age Z-scores were not significantly different between the test and control groups. Both formulas were well tolerated and reduced allergic symptoms; the number of adverse events was not different between the groups. CONCLUSIONS: This is the first study that shows that an AAF with a specific synbiotic blend, suitable for CMA infants, supports normal growth and growth similar to the AAF without synbiotics. This clinical trial is registered as NCT00664768. SN - 1399-3038 UR - https://www.unboundmedicine.com/medline/citation/25845680/Synbiotics_supplemented_amino_acid_based_formula_supports_adequate_growth_in_cow's_milk_allergic_infants_ L2 - https://doi.org/10.1111/pai.12390 DB - PRIME DP - Unbound Medicine ER -