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

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ClinicalTrials.gov Identifier: NCT01669603
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
DuPont Nutrition and Health
Information provided by (Responsible Party):
Ronald Turner, MD, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Common Cold
Interventions Dietary Supplement: Bifidobacterium lactis Bl-04
Dietary Supplement: Placebo
Biological: Rhinovirus
Enrollment 789

Recruitment Details  
Pre-assignment Details 789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.
Arm/Group Title Bifidobacterium Animalis Lactis Bl-04 Placebo
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 95 95
Completed 58 57
Not Completed 37 38
Arm/Group Title Bifidobacterium Animalis Lactis Bl-04 Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 95 95 190
Hide Baseline Analysis Population Description
Volunteers challenged with rhinovirus who met protocol definitions for analysis.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 115 participants
<=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]
Measure Analysis Population Description: 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, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 57 participants 115 participants
22  (6) 23  (7) 23  (7)
[1]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 115 participants
Female
39
  67.2%
33
  57.9%
72
  62.6%
Male
19
  32.8%
24
  42.1%
43
  37.4%
[1]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 115 participants
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]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 115 participants
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]
Measure Analysis Population Description: 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants 95 participants 190 participants
95 95 190
1.Primary Outcome
Title Interleukin-8 (IL-8)
Hide Description Nasal lavage will be performed to collect and measure IL-8.
Time Frame 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Bifidobacterium Animalis Lactis Bl-04 Placebo
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 58 57
Geometric Mean (Standard Deviation)
Unit of Measure: pg/ml
133  (2.5) 122  (2.9)
Time Frame 7 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bifidobacterium Animalis Lactis Bl-04 Placebo
Hide Arm/Group Description

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 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.

All-Cause Mortality
Bifidobacterium Animalis Lactis Bl-04 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bifidobacterium Animalis Lactis Bl-04 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/95 (0.00%)      0/95 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bifidobacterium Animalis Lactis Bl-04 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/95 (4.21%)      1/95 (1.05%)    
Gastrointestinal disorders     
gastrointestinal   4/95 (4.21%)  4 0/95 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
respiratory   0/95 (0.00%)  0 1/95 (1.05%)  1
Indicates events were collected by systematic assessment
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
Responsible Party: Ronald Turner, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01669603     History of Changes
Other Study ID Numbers: 16241
First Submitted: August 16, 2012
First Posted: August 21, 2012
Results First Submitted: March 8, 2017
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017