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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05634603
Other study ID # WCHAnGiang
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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