Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country

Study Overview
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Brief Summary
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The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.

Detailed Description
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Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.

Official Title
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Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Dietary Supplement: Lactose- free milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants on artificial milk formula Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools). Exclusion Criteria: Exclusively or partially breast-fed infants Severe dehydration requiring hospitalization

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactose-free milk<br>Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. | Dietary Supplement: Lactose- free milk<br>* Lactose- free milk<br>|
| No Intervention: Regular infant milk<br>Regular infant milk formula and anti-diarrheic diet for 7 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea Duration | number of days with 3 or more loose or watery stools | From onset of illness till the day of last diarrheic stool passed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Percent weight loss from baseline | 7 days | 
| Illness Visits | Number of participants with illness visits | 7 days | 
| Hospitalization Rate | Rate of hospitalization | 7 days | 
| Parental Satisfaction | Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied). | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, developing world, lactose-free diet, Clinical trial