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Published on: January 27, 2019
Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: a pilot study
1Pediatric Gastroenterology and Nutrition Unit, Soroka Medical Center, P.O. Box 151, Beer-Sheva 84101, Israel. wzvi@bgumail.bgu.ac.il
Insights
Two probiotic formulas containing Bifidobacterium lactis or Lactobacillus reuteri were found safe and well-tolerated in infants. These probiotic supplements did not negatively impact infant growth, feeding, or behavior.
Area of Science:
- Pediatric Nutrition
- Gastroenterology
- Microbiology
Background:
- Infant formula selection is crucial for growth and development.
- Probiotics are increasingly studied for their potential health benefits in infants.
- Safety and tolerance are primary concerns when introducing new formula ingredients.
Purpose of the Study:
- To evaluate the safety and tolerance of infant formulas supplemented with specific probiotic strains.
- To compare the effects of Bifidobacterium lactis (BB-12) and Lactobacillus reuteri (ATCC 55730) supplemented formulas against a placebo formula.
Main Methods:
- A prospective, randomized, placebo-controlled trial was conducted.
- Healthy, full-term infants under 4 months received one of three formulas for 4 weeks.
- Outcomes included growth parameters, feeding, stooling, behavior, and adverse events.
Main Results:
- Fifty-nine infants participated, with no significant baseline differences between groups.
- Both supplemented formulas were well-accepted and showed no adverse effects.
- No significant differences were observed in growth, feeding, stooling, or behavior between the probiotic and placebo groups.
Conclusions:
- Formulas supplemented with Lactobacillus reuteri or Bifidobacterium lactis are safe and well-tolerated in early infancy.
- These probiotic supplements do not adversely affect infant growth, stooling habits, or behavior.
- The findings support the use of these specific probiotic strains in infant formulas.
Objective:
To compare the safety and tolerance of two formulas, supplemented with different probiotic agents, in early infancy.
Design:
Prospective randomized placebo-controlled trial.
Setting:
Clinics of a University Medical Center.
Subjects:
Full-term healthy infants aged less than 4 months.
Intervention:
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.
Measures Of Outcome:
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.
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