Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Completed · Not applicable · Has a placebo group
Conditions studied: Common Cold
In brief
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.
Key facts
- Study ID
- NCT01669603
- Run by
- University of Virginia
- People needed
- 789
- Starts
- 2012-08-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2017-04-25
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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