Trials / Completed
CompletedNCT02679807
Effect of Probiotic on Rhinovirus Induced Colds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bifidobacterium animalis subsp. lactis Bl-04 | |
| OTHER | sucrose |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2018-04-01
- Completion
- 2018-04-01
- First posted
- 2016-02-10
- Last updated
- 2020-03-25
- Results posted
- 2020-03-17
Source: ClinicalTrials.gov record NCT02679807. Inclusion in this directory is not an endorsement.