The comparison of the effect of yogurt versus exogenous lactase enzyme in reducing frequency of stool in admitted children aged 6-24 months having persistent diarrhea with lactose intolerance: A clinical trial

Abstract

Background: Persistent diarrhea complicated with secondary lactose intolerance is a significant cause of morbidity in children mostly in low-resource settings. Impaired lactase activity following intestinal mucosal injury contributes to ongoing osmotic diarrhea and nutritional deterioration. Both fermented milk products and exogenous lactase supplementation are used therapeutically but direct comparative evidence remains limited.

Objective: To compare the efficacy of exogenous lactase enzyme supplementation versus yogurt in reducing stool frequency among hospitalized children aged 6–24 months with persistent diarrhea and laboratory-confirmed lactose intolerance.

Methods: A randomized open-label parallel-group clinical trial was conducted at a tertiary care teaching hospital in Southern Punjab, Pakistan. One hundred eligible children were randomly allocated into two equal groups (n = 50 each). Group A received exogenous lactase enzyme added to formula milk while Group B received commercially prepared yogurt at regular feeding intervals. The primary outcome was clinical efficacy, defined as reduction to fewer than three loose stools within 24 hours in day five of treatment. Data were analyzed using SPSS version 10.0, with p < 0.05 considered statistically significant. The study was conducted in the Pediatric Unit-II of Bahawal Victoria Hospital, Bahawalpur, a tertiary care teaching hospital that serves as a major referral Centre for Southern Punjab, Pakistan

Results: Baseline characteristics were compared between groups (p > 0.05). On day five, clinical efficacy was achieved in 80% of children in the lactase group and 68% in the yogurt group. Although the lactase group demonstrated a higher response rate, the difference was not statistically significant (p = 0.18). Stratified analyses with age, gender and baseline stool frequency revealed no significant effect modification.

Conclusion: Both exogenous lactase enzyme supplementation and yogurt were effective in reducing stool frequency in children with persistent diarrhea and lactose intolerance. The absence of a statistically significant difference suggests that either intervention can be used based on availability, cost and clinical context, particularly in resource-limited settings. Ref No. College of Physicians and Surgeons Pakistan (CPSP), CPSP/REU/PED-2012032-2395, 25/11/ 2025 to 25/02/2026, retrospectively registered.