Milk protein-based infant formula containing rice starch and low lactose reduces common regurgitation in healthy term infants: a randomized, blinded, and prospective trial.
OBJECTIVE
Spit-up (regurgitation) reduction with prethickened milk protein-based infant formulas containing rice starch has been clinically demonstrated in infants with heavy spit-ups but not in otherwise healthy normal infants with common spit-ups. The objective of this study was to evaluate growth, gastrointestinal tolerance, and efficacy to reduce common spit-up in normal, healthy term infants fed an investigational rice starch prethickened lactose-free milk protein-based infant formula.


METHODS
This double-blind, randomized, parallel study evaluated the investigational rice starch prethickened lactose-free (low lactose < 100 mg/L) milk protein-based infant formula compared to a standard, commercially available, iso-nutrient, lactose-containing (100% of carbohydrate) milk-based infant formula (control) for growth and gastrointestinal tolerance in healthy term infants (n = 132/group) fed from 14 ± 3 days to 112 days of age. Data were classified and analyzed as evaluable (EV; subjects completing study per protocol) or intent-to-treat data (ITT; all subjects with available data).


RESULTS
Growth as indicated by weight gain (primary variable) and formula intake were not significantly different (p > 0.05) between feeding groups (EV or ITT). Though both formulas were well tolerated, spit-up frequency was significantly lower (p < 0.05) in the rice versus control group by 53% at 28 days of age, 54% at 56 days, 48% at 84 days, and 32% at 112 days (EV). Importantly, infants in the rice group were 1.6 to 1.8 times more likely to report zero spit-up than infants in the control group. The rice group also had higher percentages of soft and yellow stools.


CONCLUSIONS
The rice starch prethickened lactose-free milk protein-based formula (rice) supported normal growth and safe use as the sole source of feeding for normal infants over the first 4 months of life. The rice formula was efficacious in providing a clinically relevant reduction of spit-up frequency in otherwise healthy term infants.
a Pediatric Nutrition R&D, Abbott Nutrition, Abbott Laboratories , Columbus , Ohio.
John B
JB
Lasekan
Hawley K
HK
Linke
Jeffery S
JS
Oliver
Jane D
JD
Carver
Mark M
MM
Blatter
Matthew J
MJ
Kuchan
Jenna M
JM
Cramer
Paul F
PF
Pollack
D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D007785:Lactose / Q000032:analysis*; D057045:Laryngopharyngeal Reflux / Q000517:prevention & control*; D008297:Male; D008894:Milk Proteins / Q000032:analysis*; D012275:Oryza; D011446:Prospective Studies; D013213:Starch; D016896:Treatment Outcome
D008894:Milk Proteins; D013213:Starch; D007785:Lactose
gastrointestinal tolerance; growth; low lactose; reflux; regurgitation; rice starch; spit-up; term infants