PMID- 24216543 OWN - NLM STAT- MEDLINE DCOM- 20141016 LR - 20220408 IS - 1530-0447 (Electronic) IS - 0031-3998 (Linking) VI - 75 IP - 2 DP - 2014 Feb TI - Effects on growth and tolerance and hypoallergenicity of an amino acid-based formula with synbiotics. PG - 343-51 LID - 10.1038/pr.2013.211 [doi] AB - BACKGROUND: To evaluate the effects of an amino acid-based formula (AAF) with synbiotics on growth and tolerance in healthy infants. The hypoallergenicity of this AAF with synbiotics was evaluated in subjects with cow's milk allergy (CMA). METHODS: Study 1: 115 full-term, healthy infants randomly received an AAF with synbiotics or a commercially available AAF for 16 wk. Subjects' weight, length, and head circumference were primary outcome measures. Stool characteristics and gastrointestinal (GI) symptoms were secondary outcome measures. Clinical examinations, dietary intake, clinical laboratory results, and adverse events were recorded. Study 2: hypoallergenicity of the AAF with synbiotics was evaluated in 30 infants and children with immunoglobulin E (IgE)-mediated CMA using a double-blind, placebo-controlled food challenge, and a 7-d feeding period. RESULTS: Study 1: comparable results in growth parameters and tolerance were observed for both groups. Minimal differences were observed in stool characteristics and GI symptoms throughout the study. Study 2: all 30 subjects with IgE-mediated CMA completed the study with no allergic reactions detected to challenges. CONCLUSION: These studies demonstrate that an AAF with synbiotics is safe and well tolerated and promotes normal growth when fed to healthy full-term infants as the sole source of nutrition and is hypoallergenic in subjects with CMA. FAU - Harvey, Bryan M AU - Harvey BM AD - Children's Investigational Research Program, LLC (CHIRP), Bentonville, Arkansas. FAU - Langford, Jane E AU - Langford JE AD - Research & Development, Nutricia Advanced Medical Nutrition, Liverpool, UK. FAU - Harthoorn, Lucien F AU - Harthoorn LF AD - Research & Development, Nutricia Advanced Medical Nutrition, Liverpool, UK. FAU - Gillman, Sherwin A AU - Gillman SA AD - Children's Hospital of Orange County, Orange, California. FAU - Green, Todd D AU - Green TD AD - Division of Pulmonary Medicine, Allergy & Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania. FAU - Schwartz, Richard H AU - Schwartz RH AD - Department of Pediatrics, Inova Fairfax Hospital for Children, Falls Church, Virginia. FAU - Burks, A Wesley AU - Burks AW AD - Division of Pediatric Allergy & Immunology, Duke University Medical Center, Durham, North Carolina. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20131111 PL - United States TA - Pediatr Res JT - Pediatric research JID - 0100714 RN - 0 (Allergens) RN - 0 (Amino Acids) RN - 0 (Oligosaccharides) RN - 37341-29-0 (Immunoglobulin E) SB - IM MH - Allergens MH - Amino Acids/*chemistry MH - Animals MH - Bifidobacterium/metabolism MH - Cattle MH - Double-Blind Method MH - Female MH - Humans MH - Immune Tolerance MH - Immunoglobulin E/chemistry MH - Infant MH - Infant Formula/administration & dosage/*chemistry MH - Male MH - Milk Hypersensitivity/*immunology MH - Oligosaccharides/chemistry MH - Probiotics/chemistry MH - *Synbiotics EDAT- 2013/11/13 06:00 MHDA- 2014/10/17 06:00 CRDT- 2013/11/13 06:00 PHST- 2012/12/17 00:00 [received] PHST- 2013/05/30 00:00 [accepted] PHST- 2013/11/13 06:00 [entrez] PHST- 2013/11/13 06:00 [pubmed] PHST- 2014/10/17 06:00 [medline] AID - pr2013211 [pii] AID - 10.1038/pr.2013.211 [doi] PST - ppublish SO - Pediatr Res. 2014 Feb;75(2):343-51. doi: 10.1038/pr.2013.211. Epub 2013 Nov 11.