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

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