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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Lactose-free milk formula (Frisolac LF ®)

Group Type ACTIVE_COMPARATOR

Lactose-free milk formula (Frisolac LF ®)

Intervention Type DIETARY_SUPPLEMENT

Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula

Placebo

Regular infant milk formula

Group Type PLACEBO_COMPARATOR

Lactose-free milk formula (Frisolac LF ®)

Intervention Type DIETARY_SUPPLEMENT

Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No