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

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 160
• Participant gender: Both

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Collaborator: DuPont Nutrition and Health
• Last Updated: 2014-12-01

Criteria

Inclusion Criteria:

AT ENROLLMENT:

• Subject must be 18-60 years of age.

• Subject must read and sign a copy of the approved Consent Form

• Female subjects must be using an effective birth control method.

INCLUSION CRITERIA AT DAY -28

• Subject must read and sign a copy of the approved Consent Form

AT CHALLENGE:

• Female subjects must be using an effective birth control method.

• Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39

Exclusion Criteria:

AT ENROLLMENT:

• Current cancer diagnosis or immunosuppressive therapy in the last 6 months

• Any clinically significant abnormalities of the upper respiratory tract

• Any clinically significant acute or chronic respiratory illness

• Any clinically significant bleeding tendency by history

• Hypertension that requires treatment with antihypertensive medications

• History of angina or other clinically significant cardiac disease

• Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study

• History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks

• History of drug or alcohol abuse in the 6 months preceding the study

EXCLUSION CRITERIA AT DAY -28

• Antibiotic use within 3 months prior to study start

• Female subjects with a positive urine pregnancy screen.

• History of use of probiotics in the preceding 2 weeks.

EXCLUSION CRITERIA AT CHALLENGE:

• Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study

• Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study

• Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two weeks prior to the study