Lactose vs. lactose free regimen in children with acute diarrhoea: a ramdomized controlled trial / Dieta con o sin lactosa en niños con diarrea aguda: un experimento clínico aleatorio

ABSTRACT

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). 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 autcome was the duration of diarrhea after refeeding, both hours and days. Secondary autcomes were evaluated by blind observers. Results were compared using t test, the Mann-Whitney test and Chi square. 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 per cent 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 fing a 50 per cent (27 h) reduction of AD duration was 71 per cent. Although the power of this trial was slightly bellow that previously fixed (80 per cent), the results suggest that routine use of lactose free formula does not reduce the duration of AD in hospitalized