Abstract
BACKGROUND: Acute diarrhea is the most common gastrointestinal disease in children under five years of age and is associated with significant morbidity and mortality risks. Lactose-free formulas may be beneficial for hospitalized patients. AIM: To compare the efficacy, safety, and cost-effectiveness of a medium-chain triglyceride-containing lactose-free formula (MLF) with a standard lactose-free formula (SLF) in children hospitalized with acute diarrhea. METHODS: In this randomized, double-blind, controlled trial, children aged 6-24 months were randomized to receive MLF or SLF. The primary outcomes were the duration until diarrhea resolution and the frequency of stools after enrollment. Secondary outcomes included length of hospital stay, treatment costs, and caregiver satisfaction. RESULTS: Forty-four children completed the study (MLF = 22, SLF = 22). The median duration of diarrhea after enrollment did not differ significantly between the groups, 24.0 hours [interquartile range (IQR): 21.5] vs 45.0 hours (IQR: 49.0); P = 0.293. The reduction in stool frequency was also comparable [7.5 (IQR: 5.8) vs 4.0 (IQR: 3.8) times/day; P = 0.083]. The Hodges-Lehmann estimated median difference in diarrhea duration was -4 hours (95% confidence interval: -26.0 to 2.0), supporting the noninferiority of MLF. The median length of hospital stay was 2 days in both groups. Formula costs were significantly lower in the MLF group (227.9 Thai Baht vs 373.6 Thai Baht; P < 0.001). Caregiver satisfaction, product acceptance, and safety profiles were comparable between the groups. CONCLUSION: MLF demonstrated noninferior clinical outcomes and safety compared to SLF, with a significant reduction in formula-related costs. MLF could be an appropriate alternative for the management of acute diarrhea in young children, especially in resource-constrained settings.