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.