title: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children.
abstract: This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001). The duration of diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.
authors.affiliation: Servicio de Pediatría del Hospital del Sureste de Arganda del Rey, Madrid, Spain.
authors.forename: Emilia
authors.initials: E
authors.lastname: García-Menor
authors.affiliation: Consulta de Pediatría del Hospital Virgen del Mar, Madrid, Spain.
authors.forename: Fátima
authors.initials: F
authors.lastname: García-Marín
authors.affiliation: Servicio de Pediatría del Hospital Universitario de Torrejón, Madrid, Spain.
authors.forename: Raquel
authors.initials: R
authors.lastname: Vecino-López
authors.affiliation: Consulta de Pediatría de la Clínica Santa Elena, Madrid, Spain.
authors.forename: Gloria
authors.initials: G
authors.lastname: Horcajo-Martínez
authors.affiliation: Consulta de Pediatría del Centro Médico del Val, Madrid, Spain.
authors.forename: María-José
authors.initials: MJ
authors.lastname: de Ibarrondo Guerrica-Echevarría
authors.affiliation: Servicio de Pediatría del Hospital Universitario Juan XXIII, Tarragona, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Gómez-González
authors.affiliation: ITF Research Pharma S.L.U., Madrid, Spain.
authors.forename: Syra
authors.initials: S
authors.lastname: Velasco-Ortega
authors.affiliation: ITF Research Pharma S.L.U., Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Suárez-Almarza
authors.affiliation: ITF Research Pharma S.L.U., Madrid, Spain.
authors.forename: Concepción
authors.initials: C
authors.lastname: Nieto-Magro
keywords: Prodefen; acute diarrhea; children; efficacy; probiotic; synbiotic; tolerability