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

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634603
• Other study ID #: WCHAnGiang
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2022
• Source: The Women and Children Hospital of An Giang
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
Vietnam	Can Tho Children Hospital	Can Tho

Sponsors (2)

Lead Sponsor	Collaborator
The Women and Children Hospital of An Giang	Can Tho University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2. — View Citation

Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diarrhea duration	llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)	7 days
Secondary	Weight gain		7 days
Secondary	Severity of diarrhea according to the modified Vesikari score		7 days