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

This is an interventional basic science trial for Common Cold focused on measuring Common cold Read More

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