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

This study is ongoing, but not recruiting participants.
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: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Common Cold
Drug: Bifidobacterium lactis Bl-04
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Interleukin-8 (IL-8) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Nasal lavage will be performed to collect and measure IL-8.


Estimated Enrollment: 160
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bifidobacterium animalis lactis Bl-04
Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
Drug: 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 Comparator: Placebo
Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
Drug: Placebo
Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ronald Turner, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01669603     History of Changes
Other Study ID Numbers: 16241
Study First Received: August 16, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Common cold

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

ClinicalTrials.gov processed this record on October 22, 2014