NCT Number: NCT02679807
Effect of Probiotic on Rhinovirus Induced Colds
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.
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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sucrose
OtherPrimary outcomes
-
Number of Participants With Rhinovirus-associated Illness Episodes
Time frame: 5 days
Rhinovirus-associated illness episodes: Volunteers who have both a rhinovirus infection and a symptomatic illness will be defined as having a rhinovirus-associated common cold illness.
Sponsors and collaborators
Lead sponsor
University of Virginia
Other
Collaborators
- Danisco Sweeteners Oy
Registry information
Acronym: MK EPRIC
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Feb 10, 2016
- Registry last updated
- Mar 25, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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