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

Not Applicable

Recruiting

• Conditions: Acute Gastroenteritis
• Interventions: Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)

• Registration Number: NCT05634603
• Lead Sponsor: The Women and Children Hospital of An Giang

Brief 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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study Start: 2022-12-01
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2024-12-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Children 2- 24 months old on artificial milk formula
• Acute diarrhea (3 or more loose or liquid stools per day)

Exclusion Criteria

• Used antibiotics within 3 days before admission
• Breastfeeding
• Severe dehydration, defined by a need of IV rehydration
• Malnutrition (weight/height< -3SD)
• Chronic underlying disease, immunocompromised condition or systemic infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Lactose-free milk formula (Frisolac LF ®)	Lactose-free milk formula (Frisolac LF ®)
Placebo	Lactose-free milk formula (Frisolac LF ®)	Regular infant milk formula

Primary Outcome Measures

Name	Time	Method
Change in diarrhea duration	7 days	llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)

Secondary Outcome Measures

Name	Time	Method
Weight gain	7 days
Severity of diarrhea according to the modified Vesikari score	7 days

Trial Locations

Locations (1)

Can Tho Children Hospital; 🇻🇳 Can Tho, Vietnam