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

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial

Conditions
-----------------
Acute Gastroenteritis

Intervention / Treatment
-----------------
* Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Lactose-free milk formula (Frisolac LF ®) | Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)<br>* Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula<br>|
| Placebo Comparator: Placebo<br>Regular infant milk formula | Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)<br>* Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 7 days | 
| Severity of diarrhea according to the modified Vesikari score |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diarrhea lactose-free diet