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

Last updated: November 21, 2022
Sponsor: The Women and Children Hospital of An Giang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroenteritis

Treatment

N/A

Clinical Study ID

NCT05634603
WCHAnGiang
  • Ages 2-24
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 66
Study Start date:
December 01, 2022
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Can Tho Children Hospital

    Can Tho, 0292
    Vietnam

    Active - Recruiting

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