A randomized, blinded pilot clinical study was conducted to assess gastrointestinal (GI) tolerance in healthy, full-term infants (2-9 weeks old), whose pediatricians recommended a formula change due to perceived cow’s milk formula intolerance. Infants were randomized and exclusively fed either a commercial control soy formula (SF; n = 22), an experimental partially hydrolyzed SF (10% hydrolyzed, n = 23), or a 5% hydrolyzed SF (n = 26) for 2 weeks. Age-matched reference cohorts (n = 72) with no GI intolerance on milk-based formula were assessed in parallel. Results indicated that all SF-fed groups contributed to reduction (P < .05) in common GI tolerance symptoms to levels not different from the non-symptomatic reference cohort at study end. The control SF group had more reduced fussiness, gas, and crying and higher formed stools versus hydrolyzed SF groups. In conclusion, the study suggests that SFs reduced GI intolerance symptoms in otherwise healthy infants with poor tolerance on milk-based formulas.
American Academy of Pediatrics, Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012;129:e827-e841.
2.
American Academy of Pediatrics Committee on Nutrition. Formula feeding of term infants. In: KleinmanREGreerFR, eds. Pediatric Nutrition. 8th ed.American Academy of Pediatrics; 2019:79-112.
3.
American Academy of Pediatrics; Work Group on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 1997;100:1035-1039.
4.
O’ConnorNR. Infant formula. Am Fam Physician. 2009;79:565-570.
5.
RossenLMSimonAEHerrickKA. Types of infant formulas consumed in the United States. Clin Pediatr (Phila). 2016;55:278-285.
6.
ForsythBWCMcCarthyPLLeventhalJM. Problems of early infancy, formula changes, and mothers’ belief about their infants. J Pediatr. 1985;106:1012-1017.
7.
PolackFPKhanNMaiselsMJ. Changing partners: the dance of infant formula changes. Clin Pediatr (Phila). 1999;38:703-708.
8.
IocanoGMerollaRD’AmicoD, et al. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005;37:432-438.
9.
AlarconPATresslerRLMulvaneyALamWComerGM. Gastrointestinal tolerance of a new infant milk formula in healthy babies: an international study conducted in 17 countries. Nutrition. 2002;18:484-489.
10.
NelsonSPChenEHSyniarGMChristoffelKK. Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 1997;151:569-572.
11.
Committee on Nutrition American Academy of Pediatrics. Formula feeding of term infants. In: Pediatric Nutrition Handbook. 3rd ed.American Academy of Pediatrics, 1998;29-42.
12.
Food and Drug Administration. Rules and regulations: nutrient requirements for infant formulas (21 CFR part 107). Fed Regist. 1985;50:45106-45108.
13.
GordonCCChumleaWCRocheAF. Stature, recumbent length and weight. In: LohmanTGRocheAFMartorellR eds. Anthropometric Standardization Reference Manual. Human Kinetics Books, 1988;3-8.
14.
LasekanJOstromKJacobsJ, et al. Growth of newborn, term infants fed soy formulas for one year. Clin Pediatr (Phila). 1999;38:563-571.
15.
HoffmanDZieglerEMitmesserSHHarrisCLDiersen-SchadeDA. Soy-based infant formula supplemented with DHA and ARA supports growth and increases circulating levels of these fatty acids in infants. Lipids. 2008;43:29-35.
16.
ChurellaHRBorschelMWThomasMRBreenMJacobsJ. Growth and protein status of term infants fed soy protein formulas differing in protein content. J Am Coll Nutr. 1994;13:262-267.
17.
LasekanJBaggsGAcostaSMackeyA. Soy protein-based infant formulas with supplemental fructooligosaccharides: gastrointestinal tolerance and hydration status in newborn infants. Nutrients. 2015;7:3022-3037.
18.
OstromKMCordleCTSchallerJP, et al. Immune status of infants fed soy-based formulas with or without added nucleotides for 1 year: part 1: vaccine responses, and morbidity. J Pediatr Gastroenterol Nutr. 2002;34:137-144.
19.
CordleCWinshipTSchallerJ, et al. Immune status of infants fed soy-based formulas with or without added nucleotides for 1 year: part 2: immune cell populations. J Pediatr Gastroenterol Nutr. 2002;34:145-153.
20.
BersethCLJohnstonWHStolzSIHarrisCLMitmesserSH. Clinical response to two commonly used switch formulas occurs within one day. Clin Pediatr (Phila). 2009;48:58-65.
21.
KanabarDRandhawaMClaytonP. Improvement of infant colic following reduction of lactose load with lactase. J Hum Nutr Diet. 2001;14:359-363.
22.
InfanteDSegarraOLuyerB. Dietary treatment of colic caused by excess gas in infants: biochemical evidence. World J Gastroenterol. 2011;17:2104-2108.
23.
HugG. Defects in metabolism of carbohydrates. In: NelsonWEVaughnVCMcKayRJBehrmanRE, eds. Nelson Textbook of Pediatrics. WB Saunders; 1979:520-522.
24.
ScrimshawNSMurrayEB. The acceptability of milk and milk products in populations with a high prevalence of lactose intolerance. Am J Clin Nutr. 1988;48(4 suppl):1079-1159.
25.
SuarezFLSavaianoDArbisiPLevittMD. Tolerance to the daily ingestion of two cups of milk by individuals claiming lactose intolerance. Am J Clin Nutr. 1997;65:1502-1506.
26.
RingsEHGrandRJBullerHA. Lactose intolerance and lactase deficiency in children. Curr Opin Pediatr. 1994;6:562-567.
27.
LasekanJBJacobsJReisingerKSMontaltoMBFrantzMPBlatterMM. Lactose-free milk protein-based infant formula: impact on growth and gastrointestinal tolerance in infants. Clin Pediatr (Phila). 2011;50:330-337.
28.
LasekanJBLinkeHKOliverJS, et al. Milk protein-based infant formula containing rice starch and low lactose reduces common regurgitation in healthy term infants: a randomized, blinded and prospective trial. J Am Coll Nutr. 2014;33:136-146.
29.
LasekanJBKooWWKWaltersJNeylanMLuebbersS. Growth, tolerance and biochemical measures in healthy infants fed a partially hydrolyzed rice protein-based formula: a randomized, blinded, prospective trial. J Am Coll Nutr. 2006;25:12-19.
30.
FayadIMHashemMHusseinAZikriMAZikriMASantoshamM. Comparison of soy-based formulas with lactose and with sucrose in the treatment of acute diarrhea in infants. Arch Pediatr Adolesc Med. 1999;153:675-680.
31.
HostA. Frequency of cow’s milk allergy in childhood. Ann Allergy Asthma Immunol. 2002;89(6suppl 1):33-37.
32.
KatzYGutierrez-CastrellonPGonzálezMGRivasRLeeBWAlarconP. A comprehensive review of sensitization and allergy to soy-based products. Clin Rev Allergy Immunol. 2014;46:272-281. doi:10.1007/s12016-013-8404-9
33.
BhatiaJGreerF; American Academy of Pediatrics Committee on Nutrition. Use of soy protein-based formulas in infant feeding. Pediatrics. 2008;121:1062-1068.
