CLINICAL TRIAL OF PROBIOTIC-FORTIFIED FORMULA FOR REDUCING ANTIBIOTIC-ASSOCIATED DIARRHEA IN INFANTS

Abstract

Objective: Antibiotic-associated diarrhea is a common complication in infancy that can interfere with feeding, prolong hospitalization, and increase the risk of dehydration. This study was conducted to assess whether an infant formula fortified with probiotics could reduce the occurrence and severity of antibiotic-associated diarrhea among hospitalized infants.

Methods: A randomized, double-blind clinical trial was carried out at tertiary-care hospitals in North Pakistan. Infants who required systemic antibiotic therapy and were receiving formula feeding were randomly assigned to receive either a probiotic-fortified formula or an identical standard formula without probiotics. The assigned formula was given throughout the course of antibiotic treatment and for a defined follow-up period after antibiotic completion. The primary outcome was the development of antibiotic-associated diarrhea. Secondary outcomes included duration of diarrhea, stool frequency, need for rehydration therapy, interruption of antibiotic treatment, length of hospital stay, and occurrence of adverse events. Data were analyzed using intention-to-treat principles.

Results: Infants receiving probiotic-fortified formula showed a substantially lower incidence of antibiotic-associated diarrhea compared with those receiving standard formula. Among infants who developed diarrhea, the probiotic group experienced shorter symptom duration and fewer daily stools. The need for intravenous rehydration and interruption of antibiotic therapy was also less frequent in the intervention group. The probiotic-fortified formula was well tolerated, and no serious adverse events related to probiotic use were observed.

Conclusion: The findings of this study indicated that probiotic-fortified infant formula was effective in reducing both the frequency and severity of antibiotic-associated diarrhea in hospitalized infants. Incorporating probiotics into routine formula feeding during antibiotic therapy may offer a practical and safe strategy to support gastrointestinal health in infancy, particularly in settings with high antibiotic use.