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OM-85 BV for primary prevention of recurrent airway infections: a pilot randomized, double-blind, placebo-controlled study. 2020

Fátima Cleonice de Souza, and Magáli Mocellin, and Renata Ongaratto, and Lidiane Alves de Azeredo Leitão, and Frederico Orlando Friedrich, and Victória d'A Silveira, and Marcelo Comerlato Scotta, and Paulo Márcio Pitrez, and Leonardo Araújo Pinto
Universidade de Santa Cruz do Sul , Santa Cruz do Sul , RS , Brazil .

OBJECTIVE To compare the frequency of respiratory tract infections in children treated with OM-85 BV and placebo during the 3-month therapy period, and observation for a further 3 months after treatment. METHODS A randomized, double-blind, placebo-controlled trial was conducted with 54 children (6 months to 5 years old) with no past history of recurrent respiratory infections attending daycare center. Family members were instructed to administer one capsule per day for 10 consecutive days, for 3 months of OM-85 BV or placebo. Telephone interviews were conducted every 30 days. RESULTS There was no significant difference in the number of respiratory infections between the groups. The mean number of respiratory tract infection in the OM-85 BV Group in the first 3 months was 0.92±0.87, and in the Placebo Group was 0.74±1.02, and at 6 months it was 1.62±1.47 and 1.03±1.34, respectively. CONCLUSIONS OM-85 BV was not effective in the primary prevention of respiratory tract infections. Although most authors recommend the use of this immunostimulant in children with a history of recurrent respiratory infections, more studies are needed to define its usefulness in the primary prevention of respiratory infections in healthy children exposed to few risk factors.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D008297 Male Males
D010865 Pilot Projects Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work. Pilot Studies,Pilot Study,Pilot Project,Project, Pilot,Projects, Pilot,Studies, Pilot,Study, Pilot
D011322 Primary Prevention Specific practices for the prevention of disease or mental disorders in susceptible individuals or populations. These include HEALTH PROMOTION, including mental health; protective procedures, such as COMMUNICABLE DISEASE CONTROL; and monitoring and regulation of ENVIRONMENTAL POLLUTANTS. Primary prevention is to be distinguished from SECONDARY PREVENTION and TERTIARY PREVENTION. Prevention, Primary,Disease Prevention, Primary,Prevention, Primordial,Primordial Prevention,Disease Preventions, Primary,Preventions, Primordial,Primary Disease Prevention,Primary Disease Preventions,Primordial Preventions
D012141 Respiratory Tract Infections Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases. Respiratory System Infections,Upper Respiratory Tract Infection,Upper Respiratory Tract Infections,Infections, Respiratory,Infections, Respiratory Tract,Infections, Upper Respiratory,Infections, Upper Respiratory Tract,Respiratory Infections,Upper Respiratory Infections,Infection, Respiratory System,Infection, Respiratory Tract,Respiratory Infection, Upper,Respiratory System Infection,Respiratory Tract Infection
D001942 Breast Feeding The nursing of an infant at the breast. Breast Fed,Breastfed,Milk Sharing,Wet Nursing,Breast Feeding, Exclusive,Breastfeeding,Breastfeeding, Exclusive,Exclusive Breast Feeding,Exclusive Breastfeeding,Sharing, Milk
D002457 Cell Extracts Preparations of cell constituents or subcellular materials, isolates, or substances. Cell Extract,Extract, Cell,Extracts, Cell
D002656 Child Day Care Centers Facilities which provide care for pre-school and school-age children. Day Care Centers for Children,Child Daycare Centers,Daycare Centers for Children,Child Daycare Center
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked

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