Effects on growth and tolerance and hypoallergenicity of an amino acid-based formula with synbiotics.
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.


CONCLUSIONS
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.
Children's Investigational Research Program, LLC (CHIRP), Bentonville, Arkansas.
Bryan M
BM
Harvey
Research & Development, Nutricia Advanced Medical Nutrition, Liverpool, UK.
Jane E
JE
Langford
Research & Development, Nutricia Advanced Medical Nutrition, Liverpool, UK.
Lucien F
LF
Harthoorn
Children's Hospital of Orange County, Orange, California.
Sherwin A
SA
Gillman
Division of Pulmonary Medicine, Allergy & Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.
Todd D
TD
Green
Department of Pediatrics, Inova Fairfax Hospital for Children, Falls Church, Virginia.
Richard H
RH
Schwartz
Division of Pediatric Allergy & Immunology, Duke University Medical Center, Durham, North Carolina.
A Wesley
AW
Burks
D000485:Allergens; D000596:Amino Acids / Q000737:chemistry*; D000818:Animals; D001644:Bifidobacterium / Q000378:metabolism; D002417:Cattle; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007108:Immune Tolerance; D007073:Immunoglobulin E / Q000737:chemistry; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage / Q000737:chemistry*; D008297:Male; D016269:Milk Hypersensitivity / Q000276:immunology*; D009844:Oligosaccharides / Q000737:chemistry; D019936:Probiotics / Q000737:chemistry; D058616:Synbiotics
D000485:Allergens; D000596:Amino Acids; D009844:Oligosaccharides; D007073:Immunoglobulin E