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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Lactose- free milk
American University of Beirut Medical Center
Beirut, Lebanon
Diarrhea Duration
number of days with 3 or more loose or watery stools
Time frame: From onset of illness till the day of last diarrheic stool passed.
Weight Loss
Percent weight loss from baseline
Time frame: 7 days
Illness Visits
Number of participants with illness visits
Time frame: 7 days
Hospitalization Rate
Rate of hospitalization
Time frame: 7 days
Parental Satisfaction
Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Time frame: 7 days
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