Common Cold
Conditions
Brief 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.
Interventions
OTHERsucrose
Sponsors
Danisco Sweeteners Oy
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Rhinovirus-associated Illness Episodes | 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. |
Participant flow
Pre-assignment details
All volunteers who signed consent were considered enrolled in the study per UVA IRB policy. 334 of these 380 volunteers were randomized to treatment after pre-treatment screening was complete.
Participants by arm
| Arm | Count |
|---|---|
| Bifidobacterium Lactis Bl-04 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 (DuPont Nutrition and Health) mixed with 1g of sucrose as a carrier
Bifidobacterium animalis subsp. lactis Bl-04 | 165 |
| Placebo sucrose
sucrose | 169 |
| Total | 334 |
Baseline characteristics
| Characteristic | Placebo | Total | Bifidobacterium Lactis Bl-04 |
|---|---|---|---|
| Age, Continuous | 22.2 years STANDARD_DEVIATION 6 | 22.2 years STANDARD_DEVIATION 6.4 | 22.3 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 17 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants | 262 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 28 Participants | 55 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 32 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 22 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) White | 120 Participants | 243 Participants | 123 Participants |
| Sex: Female, Male Female | 94 Participants | 200 Participants | 106 Participants |
| Sex: Female, Male Male | 75 Participants | 134 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 165 | 0 / 169 |
| other Total, other adverse events | 89 / 165 | 84 / 169 |
| serious Total, serious adverse events | 1 / 165 | 0 / 169 |
Outcome results
Primary
Number of Participants With Rhinovirus-associated Illness Episodes
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.
Time frame: 5 days
Population: Volunteers who were challenged with rhinovirus, completed the study period and did not have any evidence by PCR or serology of a viral infection with a virus other than the challenge virus
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bifidobacterium Lactis Bl-04 | Number of Participants With Rhinovirus-associated Illness Episodes | 63 Participants |
| Placebo | Number of Participants With Rhinovirus-associated Illness Episodes | 60 Participants |