N/A
N=334
Effect of Probiotic on Rhinovirus Induced Colds
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT02679807 ↗Enrolled (actual)
334
Serious AEs
0.3%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With Rhinovirus-associated Illness Episodes — 63; 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bifidobacterium animalis subsp. lactis Bl-04 (Biological); sucrose (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Rhinovirus-associated Illness Episodes |
63; 60 | — |
Summary
This is a randomized, double-blind placebo controlled trial to evaluate the effect of a probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the experimental rhinovirus challenge model. A previous study documented that Bl-04 has significant effects on the innate immune response in the nose and this study will be powered to assess whether these effects translate into a demonstrable clinical benefit. Volunteers will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary analysis will be on the proportion of volunteers who develop a rhinovirus associated illness in the two treatment groups.
Eligibility Criteria
Inclusion 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
- Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39
INCLUSION CRITERIA AT DAY -28
- Female subjects must be using an effective birth control method.
INCLUSION CRITERIA AT CHALLENGE:
- Female subjects must be using an effective birth control method.
Exclusion Criteria
- Antibiotic use within 3 months prior to day -28
- Female subjects with a positive urine pregnancy screen
- History of use of probiotics in the preceding two weeks
- 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 CHALLENGE:
- Any upper respiratory infection or allergic rhinitis in the two weeks prior to the challenge
- Female subjects with positive pregnancy screen prior to challenge
- 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 or allergy preparation in the two weeks prior to the challenge
Data sourced from ClinicalTrials.gov (NCT02679807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.