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Randomized multicenter trial documenting the efficacy and safety of a lactose-free and a lactose-containing formula
J Heubi1, R Karasov, K Reisinger
1Division of Pediatric Gastroenterology and Nutrition, Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Insights
This study found a new lactose-free infant formula to be safe and effective. It supports healthy growth and development as a suitable alternative nutrition for infants needing a lactose-free diet.
Area of Science:
- Pediatrics
- Nutritional Science
- Infant Health
Background:
- Lactose intolerance affects some infants, necessitating specialized feeding solutions.
- Developing safe and effective lactose-free infant formulas is crucial for infant nutrition.
- This study addresses the need for evaluating new dietary options for infants.
Purpose of the Study:
- To assess the efficacy and safety of a novel lactose-free infant formula.
- To compare growth parameters and tolerance of the new formula against a standard one.
- To determine the suitability of the lactose-free formula for term infants.
Main Methods:
- A 12-week, randomized, prospective, double-blind, controlled, multicenter trial involving 137 healthy term infants.
- Infants were assigned to either the new lactose-free formula or a control formula.
- Growth (weight, length, head circumference), formula acceptance, tolerance, and key blood parameters were monitored.
Main Results:
- 104 infants completed the study.
- No statistically significant differences were observed in growth parameters (weight, length, occipitofrontal circumference) between the two formula groups.
- Laboratory values (serum albumin, creatinine, BUN) and adverse events showed no significant variations between groups.
Conclusions:
- The new lactose-free infant formula is demonstrated to be an effective and safe nutritional alternative.
- It supports normal infant growth and development comparable to standard formulas.
- This formula provides a viable option for infants requiring a lactose-free diet.
Objective:
To evaluate the efficacy and safety of a new lactose-free infant formula.
Design:
Randomized, prospective, double-blind, controlled, outpatient, multicenter, parallel 12-week trial.
Setting:
Ambulatory-care facilities of the participating centers.
Subjects:
137 healthy term infants (approximately 7 days old at the time of study enrollment).
Intervention:
Healthy term infants, whose mothers had decided not to breast-feed, were randomly assigned 1 of the 2 study formulas.
Main Outcome Measures:
Weight, length, and occipitofrontal circumference measurements were obtained at baseline and when the infant was 2, 4, 8, and 12 weeks old. Formula acceptance and tolerance were also assessed at weeks 2, 4, 8, and 12. Serum albumin concentration, creatirune level, and blood urea nitrogen were determined at baseline and week 12. Adverse events were assessed throughout the study.
Statistical Analyses Performed:
Each baseline anthropometric and laboratory variable was analyzed for comparability between groups using the Student t test and was also analyzed using a repeated-measures analysis of variance method. Covariance analysis was applied to the final laboratory data using the respective baseline data as covariates. Decisions about equality of mean responses to formula effects were based on the .05 level of significance in all cases.
Results:
One hundred four infants completed the study. No significant differences between the 2 formula groups were noted for any of the growth and blood parameters.
Applications:
This new formula is an effective and safe lactose-free nutrition alternative for infants who require such a diet.
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