NCT05634603

Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants

Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: The Women and Children Hospital of An Giang · Academic / Other
• Sex: All
• Age: 2 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.

Detailed description

More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactose-free milk formula (Frisolac LF ®)	Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-12-01
• Completion: 2025-04-30
• First posted: 2022-12-02
• Last updated: 2022-12-02

Locations

1 site across 1 country: Vietnam