Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: a pilot study.
OBJECTIVE
To compare the safety and tolerance of two formulas, supplemented with different probiotic agents, in early infancy.


METHODS
Prospective randomized placebo-controlled trial.


METHODS
Clinics of a University Medical Center.


METHODS
Full-term healthy infants aged less than 4 months.


METHODS
Infants were randomly assigned for 4 weeks to a standard milk-based formula supplemented with either Bifidobacterium lactis (BB-12), Lactobacillus reuteri (ATCC 55730) or a probiotics-free formula.


METHODS
Growth parameters, daily characteristics of feeding, stooling and behavior, and side effects.


RESULTS
Fifty-nine infants, aged 3-65 days, were included. Subjects in all three groups were similar at entry in terms of gestational age, birth weight, sex, growth parameters and breast feeding rate prior to the study. The supplemented formulas were well accepted and did not reveal any adverse effects. A comparison of growth parameters, and variables of feeding, stooling and crying and irritability did not reveal any significant differences between groups.


CONCLUSIONS
The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy, was safe, well tolerated and did not adversely affect growth, stooling habits or infant behavior.
Weizman
Zvi
Z
Pediatric Gastroenterology and Nutrition Unit, Soroka Medical Center, P.O. Box 151, Beer-Sheva 84101, Israel. wzvi@bgumail.bgu.ac.il
Alsheikh
Ahmed
A
D000704:Analysis of Variance; D001644:Bifidobacterium / Q000254:growth & development*; D003672:Defecation; D005260:Female; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D041943:Infant Formula; D007231:Infant, Newborn / Q000254:growth & development*; D052200:Limosilactobacillus reuteri / Q000254:growth & development*; D008297:Male; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012449:Safety