Common Cold Clinical Trial
Official title:
Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.
The common cold is a ubiquitous illness of man that is associated with significant medical
and socioeconomic consequences. Current treatments for the common cold that have proven
efficacy are limited to pharmacologic agents that are directed at specific symptoms. These
treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness,
generally relieving the target symptom by 15-25% at the peak of activity, and are associated
with bothersome side effects. There are no currently effective treatments for prevention of
rhinovirus infections.
Probiotics have been defined by FAO/WHO as "Live microorganisms which when administered in
adequate amount confer a health benefit on a host." The most common probiotics belong to
Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants
that were discovered over a hundred years ago from the feces of breast-fed infants. The
study product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been
genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full
genome sequence comparison. Bl-04 has been deposited in the American Type Culture
Collections safe deposit as SD5219.
This study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis
subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus
infection.
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