NCT01669603

Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 789 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.

Detailed description

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.

Conditions

• Common Cold

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium lactis Bl-04	The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.
DIETARY_SUPPLEMENT	Placebo	Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
BIOLOGICAL	Rhinovirus	rhinovirus for experimental challenge

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-08-21
• Last updated: 2017-04-25
• Results posted: 2017-04-25

Locations

1 site across 1 country: United States