Acute Gastroenteritis
Conditions
Keywords
diarrhea lactose-free diet
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.
Interventions
DIETARY_SUPPLEMENTLactose-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
Sponsors
Can Tho University of Medicine and Pharmacy
The Women and Children Hospital of An Giang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Weight gain | 7 days |
| Severity of diarrhea according to the modified Vesikari score | 7 days |
Countries
Vietnam
Outcome results
None listed