Background: Pneumonia remains a major cause of morbidity and mortality among children worldwide. Evidence suggests that probiotics may modulate immune responses and potentially improve respiratory infections. This study aimed to evaluate the effect of probiotic supplementation on clinical outcomes in children aged 3 months to 12 years hospitalized with pneumonia.
Methods: In this double-blind randomized clinical trial, 108 children diagnosed with pneumonia were allocated into two groups: 54 received a daily 1‑gram sachet of Protexin probiotic (containing 1×10⁹ CFU), and 54 received a placebo matched in appearance. Clinical signs and symptoms, including fever, lethargy, tachypnea, cough, retraction, wheezing, rales, hypoxia, and length of hospital stay, were monitored at baseline and at scheduled follow-up intervals. Data analysis was performed using SPSS; t‑tests were applied for normally distributed quantitative variables and Mann–Whitney tests for non‑normal variables, with a significance level of P<0.05.
Results: No significant differences were found between the probiotic and placebo groups regarding gender, age, baseline symptoms, or length of hospital stay (P>0.05 for all). However, the frequency of fever at 36 and 60 hours after admission was significantly lower in the probiotic group (P=0.037, P=0.034), and lethargy at 36 hours after admission was significantly less common compared to the placebo group (P=0.009).
Conclusions: While most clinical parameters did not differ between groups, probiotic supplementation was associated with a significant reduction in fever and lethargy during hospitalization. Probiotics may serve as a beneficial adjunct therapy in pediatric pneumonia, although further studies with larger sample sizes and detailed clinical endpoints are recommended.