Common Cold
Conditions
Keywords
Common cold
Brief summary
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.
Detailed description
The common cold is a ubiquitous illness of man that is associated with significant medical and socioeconomic consequences. Current treatments for the common cold that have proven efficacy are limited to pharmacologic agents that are directed at specific symptoms. These treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness, generally relieving the target symptom by 15-25% at the peak of activity, and are associated with bothersome side effects. There are no currently effective treatments for prevention of rhinovirus infections. Probiotics have been defined by FAO/WHO as Live microorganisms which when administered in adequate amount confer a health benefit on a host. The most common probiotics belong to Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants that were discovered over a hundred years ago from the feces of breast-fed infants. The study product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full genome sequence comparison. Bl-04 has been deposited in the American Type Culture Collections safe deposit as SD5219. This study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus infection.
Interventions
DIETARY_SUPPLEMENTBifidobacterium lactis Bl-04
The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.
DIETARY_SUPPLEMENTPlacebo
Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
BIOLOGICALRhinovirus
rhinovirus for experimental challenge
Sponsors
DuPont Nutrition and Health
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-8 (IL-8) | 72 hours | Nasal lavage will be performed to collect and measure IL-8. |
Countries
United States
Participant flow
Pre-assignment details
789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Bifidobacterium Animalis Lactis Bl-04 Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Bifidobacterium lactis Bl-04: The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier. | 95 |
| Placebo Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. | 95 |
| Total | 190 |
Baseline characteristics
| Characteristic | Bifidobacterium Animalis Lactis Bl-04 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 57 Participants | 115 Participants |
| Age, Continuous | 22 years STANDARD_DEVIATION 6 | 23 years STANDARD_DEVIATION 7 | 23 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 52 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 52 Participants | 46 Participants | 98 Participants |
| Region of Enrollment United States | 95 participants | 95 participants | 190 participants |
| Sex: Female, Male Female | 39 Participants | 33 Participants | 72 Participants |
| Sex: Female, Male Male | 19 Participants | 24 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 95 | 1 / 95 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 |
Outcome results
Primary
Interleukin-8 (IL-8)
Nasal lavage will be performed to collect and measure IL-8.
Time frame: 72 hours
Population: analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Bifidobacterium Animalis Lactis Bl-04 | Interleukin-8 (IL-8) | 133 pg/ml | Standard Deviation 2.5 |
| Placebo | Interleukin-8 (IL-8) | 122 pg/ml | Standard Deviation 2.9 |