Prebiotic and Probiotic Fortified Milk in Prevention of Morbidities among Children: Community-Based, Randomized, Double-Blind, Controlled Trial

Abstract

BackgroundRecent reviews suggest common infectious diseases continue to be a major cause of death among preschool children in developing countries. Identification of feasible strategies to combat this disease burden is an important public health need. We evaluated the efficacy of adding prebiotic oligosaccharide and probiotic Bifidobacterium lactis HN019 to milk, in preventing diarrhea, respiratory infections and severe illnesses, in children aged 1–4 years as part of a four group study design, running two studies simultaneously.Methods and FindingsIn a community based double-masked, randomized controlled trial, children 1–3 years of age, willing to participate, were randomly allocated to receive either control milk (Co; n = 312) or the same milk fortified with 2.4 g/day of prebiotic oligosaccharide and 1.9×107 colony forming unit (c.f.u)/day of probiotic Bifidobacterium lactis HN019 (PP; n = 312). Children were followed up for 1 year providing data for 1–4 years. Biweekly household surveillance was conducted to gather information on compliance and morbidity. Both study groups were comparable at baseline; compliance to intervention was similar. Overall, there was no effect of prebiotic and probiotic on diarrhea (6% reduction, 95% Confidence Interval [CI]: −1 to 12%; p = 0.08). Incidence of dysentery episodes was reduced by 21% (95% CI: 0 to 38%; p = 0.05). Incidence of pneumonia was reduced by 24% (95% CI: 0 to 42%; p = 0.05) and severe acute lower respiratory infection (ALRI) by 35% (95% CI: 0 to 58%; p = 0.05). Compared to children in Co group, children in PP group had 16% (95% CI: 5 to 26%, p = 0.004) and 5% (95% CI: 0 to 10%; p = 0.05) reduction in days with severe illness and high fever respectively.Conclusions/SignificanceMilk can be a good medium for delivery of prebiotic and probiotic and resulted in significant reduction of dysentery, respiratory morbidity and febrile illness. Overall, impact of diarrhea was not significant. These findings need confirmation in other settings.Trial RegistrationClinicalTrials.gov NCT00255385

High-Throughput Sequencing Reveals the Incomplete, Short-Term Recovery of Infant Gut Microbiota following Parenteral Antibiotic Treatment with Ampicillin and Gentamicin

“…Consequently, this period of the infant's life represents a unique window of opportunity during which time the gut microbiota may be modified with implications for health outcomes (56). A myriad of factors that affect this composition have been investigated and include mode of delivery (56), feeding choice (i.e., breast versus formula feeding) (8,45), prematurity (63,72), and the administration of probiotics (11,15,55,60) and prebiotics (10,31,65). It is also thought that exposure to antibiotics can have a significant negative influence on the composition and development of the gut microbiota in early life (7,23,35).…”

Probiotics for Diarrhea in Children

“…Another study from urban India reported protection against dysentery (defined by a parental history of bloody diarrhea), although no impact was seen on the overall incidence of diarrhea [40].…”

Probiotics and prebiotics in prevention and treatment of diseases in infants and children

“…Em um ECR de base comunitária, crianças de 1-3 anos de idade foram distribuídas aleatoriamente em dois grupos que receberam ou um leite utilizado como controle (n = 312) ou o mesmo leite fortificado com 2,4 g/dia de oligossacarídeos prebióticos e 1,9x10 7 unidades formadoras de colônias/dia de B. lactis HN019 (n = 312) 62 . Foi realizada vigilância doméstica duas vezes por semana para obter informações sobre o cumprimento do plano do ensaio e sobre morbidade.…”

“…A incidên-cia de episódios de disenteria foi reduzida em 21% (IC95% 0-38%, p = 0,05), enquanto a incidência de pneumonia e de infecção respiratória aguda baixa grave foi reduzida em 24 (IC95% 0-42%, p = 0,05) e 35% (IC95% 0-58%, p = 0,05), respectivamente. Comparadas às crianças do grupo controle, as crianças do grupo intervenção apresentaram uma redução de 16 (IC95% 5-26%, p = 0,004) e 5% (IC95% 0-10%, p = 0,05) no número de dias com doença grave e febre alta, respectivamente 62 . Os autores concluíram que o leite pode ser um bom meio de administração de pre e probióticos 62 .…”

“…Comparadas às crianças do grupo controle, as crianças do grupo intervenção apresentaram uma redução de 16 (IC95% 5-26%, p = 0,004) e 5% (IC95% 0-10%, p = 0,05) no número de dias com doença grave e febre alta, respectivamente 62 . Os autores concluíram que o leite pode ser um bom meio de administração de pre e probióticos 62 .…”