title: Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Acute gastroenteritis is a major cause of pediatric morbidity and mortality, accounting for 15% of all childhood deaths worldwide. In developing countries, diarrheal diseases continue to be a major public health burden. Evidence from developed countries suggests that intake of lactose-free milk during diarrheal episodes may reduce the duration of the illness in pediatric inpatients. It is unknown whether lactose-free milk reduces the severity or duration of acute gastroenteritis in infants treated in outpatient settings in developing countries where diarrhea is more severe, and results in higher morbidities and mortalities. We hypothesize that lactose-free milk intake during acute gastroenteritis would significantly decrease the duration and severity of diarrhea in infants presenting to the Emergency Department (ED), as compared with lactose-containing milk.
  
  
  METHODS
  An open-label randomized clinical trial.
  
  
  METHODS
  40 infants with acute gastroenteritis, age between 2 and 12 months, presenting to the ED, will be randomized to control or intervention group.
  
  
  METHODS
  Lactose-free milk, whereas the control group will continue on regular infant formula for a total of 7 days. Infants will be followed up for 7 days.
  
  
  METHODS
  Diarrhea duration, weight loss, illness clinic visits, hospitalization rate, parental satisfaction, and time to symptom resolution.
  
  
  METHODS
  Descriptive and regression analysis will be conducted under the intention-to-treat basis by using SPSS version 21.
  
  
  CONCLUSIONS
  Acute gastroenteritis is a public health burden for developing countries, with a significant impact on infant morbidity and mortality. Provision of infant formula that may reduce the duration and severity of diarrhea can decrease this burden in countries with limited healthcare resources, like Lebanon. The findings from this study are anticipated to provide evidence-based dietary recommendations for ambulatory infants with acute diarrhea in developing countries.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02246010; September 2014.
authors.forename: Mona
authors.initials: M
authors.lastname: Nabulsi
authors.forename: Nadine
authors.initials: N
authors.lastname: Yazbeck
authors.forename: Fatme
authors.initials: F
authors.lastname: Charafeddine
mesh_terms: D000208:Acute Disease; D000367:Age Factors; D002985:Clinical Protocols; D003906:Developing Countries; D003968:Diarrhea, Infantile / Q000175:diagnosis / Q000178:diet therapy* / Q000209:etiology; D005759:Gastroenteritis / Q000175:diagnosis / Q000178:diet therapy* / Q000209:etiology; D006801:Humans; D007223:Infant; D041943:Infant Formula; D057194:Intention to Treat Analysis; D007785:Lactose / Q000009:adverse effects*; D007861:Lebanon; D041941:Milk Substitutes; D012107:Research Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007785:Lactose