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

The Women and Children Hospital of An Giang

Status: Enrolling

Conditions: Acute Gastroenteritis

Treatments: Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)

Study type: Interventional

Funder types: Other

Identifiers

NCT05634603

WCHAnGiang

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 2 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Lactose-free milk formula (Frisolac LF ®)

Treatment:

Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)

Placebo

Placebo Comparator group

Description:

Regular infant milk formula

Treatment:

Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)