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Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR) (EPIARR)

This study has been completed.
Sponsor:
Collaborator:
DuPont Nutrition and Health
Information provided by (Responsible Party):
Ronald Turner, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01669603
First received: August 16, 2012
Last updated: April 20, 2017
Last verified: April 2017
Results First Received: March 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Basic Science
Condition: Common Cold
Interventions: Dietary Supplement: Bifidobacterium lactis Bl-04
Dietary Supplement: Placebo
Biological: Rhinovirus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Bifidobacterium Animalis Lactis Bl-04   Placebo
STARTED   95   95 
COMPLETED   58   57 
NOT COMPLETED   37   38 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Volunteers challenged with rhinovirus who met protocol definitions for analysis.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   Bifidobacterium Animalis Lactis Bl-04   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 95   95   190 
Age [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 58   57   115 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      58 100.0%      57 100.0%      115 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[1] Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 58   57   115 
   22  (6)   23  (7)   23  (7) 
[1] 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
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 58   57   115 
Female      39  67.2%      33  57.9%      72  62.6% 
Male      19  32.8%      24  42.1%      43  37.4% 
[1] 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
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 58   57   115 
Hispanic or Latino      3   5.2%      4   7.0%      7   6.1% 
Not Hispanic or Latino      54  93.1%      52  91.2%      106  92.2% 
Unknown or Not Reported      1   1.7%      1   1.8%      2   1.7% 
[1] 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
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 58   57   115 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   3.4%      8  14.0%      10   8.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   5.2%      2   3.5%      5   4.3% 
White      52  89.7%      46  80.7%      98  85.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.7%      1   1.8%      2   1.7% 
[1] 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
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 95   95   190 
United States   95   95   190 


  Outcome Measures

1.  Primary:   Interleukin-8 (IL-8)   [ Time Frame: 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ronald Turner
Organization: University of Virginia
e-mail: rbt2n@virginia.edu



Responsible Party: Ronald Turner, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01669603     History of Changes
Other Study ID Numbers: 16241
Study First Received: August 16, 2012
Results First Received: March 8, 2017
Last Updated: April 20, 2017