Bryan M Harvey1, Jane E Langford2, Lucien F Harthoorn2, Sherwin A Gillman3, Todd D Green4, Richard H Schwartz5, A Wesley Burks6. 1. Children's Investigational Research Program, LLC (CHIRP), Bentonville, Arkansas. 2. Research & Development, Nutricia Advanced Medical Nutrition, Liverpool, UK. 3. Children's Hospital of Orange County, Orange, California. 4. Division of Pulmonary Medicine, Allergy & Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania. 5. Department of Pediatrics, Inova Fairfax Hospital for Children, Falls Church, Virginia. 6. Division of Pediatric Allergy & Immunology, Duke University Medical Center, Durham, North Carolina.
Abstract
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.
RCT Entities:
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.
Authors: Betty C A M van Esch; Suzanne Abbring; Mara A P Diks; Gemma M Dingjan; Lucien F Harthoorn; A Paul Vos; Johan Garssen Journal: Immun Inflamm Dis Date: 2016-03-24
Authors: Bryan M Harvey; Simone R B M Eussen; Lucien F Harthoorn; A Wesley Burks Journal: J Pediatr Gastroenterol Nutr Date: 2017-09 Impact factor: 2.839
Authors: Adam T Fox; Harm Wopereis; Marleen T J Van Ampting; Manon M Oude Nijhuis; Assad M Butt; Diego G Peroni; Yvan Vandenplas; David C A Candy; Neil Shah; Christina E West; Johan Garssen; Lucien F Harthoorn; Jan Knol; Louise J Michaelis Journal: Clin Transl Allergy Date: 2019-01-15 Impact factor: 5.871
Authors: David C A Candy; Marleen T J Van Ampting; Manon M Oude Nijhuis; Harm Wopereis; Assad M Butt; Diego G Peroni; Yvan Vandenplas; Adam T Fox; Neil Shah; Christina E West; Johan Garssen; Lucien F Harthoorn; Jan Knol; Louise J Michaelis Journal: Pediatr Res Date: 2017-12-06 Impact factor: 3.756