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Lactose vs. lactose free regimen in children with acute diarrhoea: a randomized controlled trial
1Department of Pediatrics and Clinical Epidemiology Unit, Faculty of Medicine, Universidad Javeriana, Bogota, Colombia.
Insights
Routine use of lactose-free formula in hospitalized children aged 1-24 months did not significantly reduce the duration of acute diarrhea (AD). This study suggests no benefit for lactose-free options in treating pediatric AD.
Area of Science:
- Pediatric Gastroenterology
- Clinical Nutrition
- Infectious Diseases
Background:
- Acute diarrhea (AD) is a common pediatric illness requiring nutritional management.
- The role of lactose-free formulas in managing AD in hospitalized children is debated.
Purpose of the Study:
- To evaluate if routine use of a specific lactose-free formula (AL-110) reduces AD duration in hospitalized children aged 1-24 months.
Main Methods:
- Randomized controlled trial with 52 children (28 AL-110, 24 lactose formula) stratified by age and nutritional status.
- Primary outcome: duration of diarrhea post-refeeding (hours and days).
- Secondary outcomes: treatment failure rate and weight gain, assessed by blind observers.
Main Results:
- No statistically significant difference in diarrhea duration between lactose-free and lactose-containing formulas (mean 41.9h vs 54.4h; p=0.247).
- Similar rates of treatment failure (3.6% vs 8.3%; p=0.2) and mean weight increment (0.78kg vs 0.82kg; p=0.788) were observed.
- Study power was 71% to detect a 50% reduction in AD duration.
Conclusions:
- Routine use of lactose-free formula (AL-110) does not appear to shorten the duration of acute diarrhea in hospitalized children.
- Despite slightly lower than planned study power, findings suggest no clinical advantage for lactose-free formula in this population.
Objective:
To determine whether the routine use of a lactose free formula (AL-110, Nestle Labs.) in hospitalized children aged one to 24 months reduces the duration of acute diarrhea (AD).
Methods:
After being stratified according to age and nutritional state, 28 and 24 patients were randomly allocated to receive AL-110 or lactose formula, respectively. The main outcome was the duration of diarrhoea after refeeding, both in hours and days. Secondary outcomes were evaluated by blind observers. Results were compared using t test, the Mann-Whitney test and Chi square.
Results:
No differences were found between the diets without and with lactose regarding duration of diarrhoea in hours (mean, 41.9 h vs 54.4 h; p = 0.247) or days (median, 0 d vs 0 d; p = 0.717), the percentage of failures (3.6% vs 8.3; p = 0.2), and the mean weight increment (0.78 kg vs. 0.82 kg; p = 0.788). The study power to find a 50% (27h) reduction of AD duration was 71%.
Conclusion:
Although the power of this trial was slightly below that previously fixed (80%), the results suggest that routine use of lactose free formula does not reduce the duration of AD in hospitalized children.