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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

Brief Summary:
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.

Condition or disease Intervention/treatment Phase
Common Cold Dietary Supplement: Bifidobacterium lactis Bl-04 Dietary Supplement: Placebo Biological: Rhinovirus Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Study Start Date : August 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Experimental: Bifidobacterium animalis lactis Bl-04
Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Dietary Supplement: 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.

Biological: Rhinovirus
rhinovirus for experimental challenge

Placebo Comparator: Placebo
Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Dietary Supplement: Placebo
Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.

Biological: Rhinovirus
rhinovirus for experimental challenge




Primary Outcome Measures :
  1. Interleukin-8 (IL-8) [ Time Frame: 72 hours ]
    Nasal lavage will be performed to collect and measure IL-8.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

EXCLUSION CRITERIA AT DAY -28

  • Antibiotic use within 3 months prior to study start
  • Female subjects with a positive urine pregnancy screen.
  • History of use of probiotics in the preceding 2 weeks.

EXCLUSION CRITERIA AT CHALLENGE:

  • Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
  • 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 preparation in the two weeks prior to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669603


Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
DuPont Nutrition and Health
Investigators
Principal Investigator: Ronald Turner, MD University of Virginia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald Turner, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01669603     History of Changes
Other Study ID Numbers: 16241
First Posted: August 21, 2012    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Ronald Turner, MD, University of Virginia:
Common cold

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases