title: [Efficacy and safety profile of cranberry in infants and children with recurrent urinary tract infection].
abstract: OBJECTIVE
  Cranberry prophylaxis of recurrent urinary tract infection in infants has proven effective in the experimental model of the adult. There are few data on its efficacy, safety and recommended dose in the pediatric population.
  
  
  METHODS
  A controlled, double-blind Phase III clinical trial was conducted on children older than 1 month of age to evaluate the efficacy and safety of cranberry in recurrent urinary tract infection. The assumption was of the non-inferiority of cranberry versus trimethoprim. Statistical analysis was performed using Kaplan Meier analysis.
  
  
  RESULTS
  A total of 85 patients under 1 year of age and 107 over 1 year were recruited. Trimethoprim was prescribed to 75 patients and 117 received cranberry. The cumulative rate of urinary infection associated with cranberry prophylaxis in children under 1 year was 46% (95% CI; 23-70) in children and 17% (95% CI; 0-38) in girls, effectively at doses inferior to trimethoprim. In children over 1 year-old cranberry was not inferior to trimethoprim, with a cumulative rate of urine infection of 26% (95% CI; 12-41). The cranberry was well tolerated and with no new adverse effects.
  
  
  CONCLUSIONS
  Our study confirms that cranberry is safe and effective in the prophylaxis of recurrent urinary tract infection in infants and children. With the doses used, their efficiency is not less than that observed for trimethoprim among those over 1 year-old. (Clinical Trials Registry ISRCTN16968287).
authors.affiliation: Servicio de Pediatría, Hospital Universitario San Cecilio, Granada, España.
authors.forename: V
authors.initials: V
authors.lastname: Fernández-Puentes
authors.affiliation: Servicio de Pediatría, Hospital Universitario San Cecilio, Granada, España. Electronic address: juberos@ugr.es.
authors.forename: J
authors.initials: J
authors.lastname: Uberos
authors.affiliation: Servicio de Pediatría, Hospital Universitario San Cecilio, Granada, España.
authors.forename: R
authors.initials: R
authors.lastname: Rodríguez-Belmonte
authors.affiliation: Servicio de Urología, Hospital Universitario San Cecilio, Granada, España.
authors.forename: M
authors.initials: M
authors.lastname: Nogueras-Ocaña
authors.affiliation: Servicio de Pediatría, Hospital Universitario San Cecilio, Granada, España.
authors.forename: E
authors.initials: E
authors.lastname: Blanca-Jover
authors.affiliation: Servicio de Pediatría, Hospital Universitario San Cecilio, Granada, España.
authors.forename: E
authors.initials: E
authors.lastname: Narbona-López
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003663:Decision Trees; D004311:Double-Blind Method; D005260:Female; D000067030:Fruit and Vegetable Juices / Q000009:adverse effects; D006801:Humans; D007223:Infant; D008297:Male; D008517:Phytotherapy; D012008:Recurrence; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000517:prevention & control*; D029799:Vaccinium macrocarpon
keywords: Antibiotic prophylaxis; Arándano americano; Cranberry; Infección urinaria recurrente; Profilaxis antibiótica; Reflujo vesicoureteral; Trimethoprim; Trimetoprim; Urinary tract infections; Vesicoureteral reflux