Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children.

OBJECTIVE To investigate the effects of calcium and probiotics on the incidence and duration of acute diarrhea and acute respiratory tract infections (ARTIs) in low-socioeconomic communities of Jakarta, Indonesia. METHODS We conducted a 6-month, double-blind, placebo-controlled study in 494 healthy children aged 1 to 6 years who received low-lactose milk with low calcium content (LC; ∼50 mg/day; n = 124), regular calcium content (RC; ∼440 mg/day; n = 126), RC with 5.10(8) colony-forming units per day of Lactobacillus casei CRL431 (casei; n = 120), or RC with 5.10(8) colony-forming units per day of Lactobacillus reuteri DSM17938 (reuteri; n = 124). Number and duration of diarrhea and ARTIs episodes were primary and secondary outcomes, respectively. RESULTS Incidence of World Health Organization-defined diarrhea (≥3 loose/liquid stools in 24 hours) was not significantly different between RC and LC (relative risk [RR]: 0.99 [95% confidence interval (CI): 0.62-1.58]), between casei and RC (RR: 1.21 [95% CI: 0.76-1.92]), or between reuteri and RC (RR: 0.76 [95% CI: 0.46-1.25]) groups. Incidence of all reported diarrhea (≥2 loose/liquid stools in 24 hours) was significantly lower in the reuteri versus RC group (RR: 0.68 [95% CI: 0.46-0.99]). Irrespective of the definition used, reuteri significantly reduced diarrhea incidence in children with lower nutritional status (below-median height-and-weight-for-age z score). None of the interventions affected ARTIs. CONCLUSIONS RC milk, alone or with L casei, did not reduce diarrhea or ARTIs in Indonesian children. L reuteri may prevent diarrhea, especially in children with lower nutritional status.