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.