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 reported the results of 33 randomized or quasi-randomized trials that assessed the effects of reducing or avoiding lactose in young children (<5 years) with diarrhea on the duration and/or severity of the illness. These trials have shown that lactose-free milk during these episodes might reduce the duration of illness. All trials however were conducted on inpatients and in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. In this study, we aim at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants with acute gastroenteritis presenting to the Emergency Department (ED). Forty formula-fed infants (2 to 12 months of age) presenting with acute diarrhea to the American University of Beirut Medical Center ED and outpatient clinics will be randomly allocated to one of two parallel groups in a 1:1 ratio. Controls will receive standard medical care and anti-diarrheic diet which includes dairy products and lactose-containing formula. Intervention Group will also receive standard medical care; however their milk will be lactose- free. The primary outcome is the difference in duration of diarrhea between the intervention and control groups. Secondary outcomes will include percent weight loss, proportion of infants with a return visit to the physician, proportion of infants who get hospitalized within 7 days from baseline for any cause, parental satisfaction, and rapidity of symptom resolution. 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.
Infants who are fed artificial milk formula (2 to 12 months of age) presenting with acute diarrhea to the outpatient clinics or emergency department (ED) at AUBMC.
Infants who are fed artificial milk formula (2 to 12 months of age) presenting with acute diarrhea to the outpatient clinics or emergency department (ED).
- Infants, 2 to 12 months of age, who are fed artificial milk formula
- Presenting to the ED or outpatient clinics of the American University of Beirut Medical Center
- Chief complaint: acute gastroenteritis.
Diarrhea is defined as the passage of 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.
Infants with any of the following conditions will be excluded: any breastfeeding, sepsis, chronic diarrhea, severe dehydration, inflammatory bowel disease, cow’s milk allergy, current intake of lactose-free milk, celiac disease, immune deficiency, chronic disease, malnutrition, or need of immediate hospitalization.