Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT01669603
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01669603
Study Brief:
Protocol Section:
NCT01669603