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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

Tracking Information
First Submitted Date  ICMJE August 16, 2012
First Posted Date  ICMJE August 21, 2012
Results First Submitted Date March 8, 2017
Results First Posted Date April 25, 2017
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE August 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
Interleukin-8 (IL-8) [ Time Frame: 72 hours ]
Nasal lavage will be performed to collect and measure IL-8.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01669603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Official Title  ICMJE Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Common Cold
Intervention  ICMJE
  • 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.
  • 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
Study Arms
  • Experimental: Bifidobacterium animalis lactis Bl-04
    Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.
    Interventions:
    • Dietary Supplement: Bifidobacterium lactis Bl-04
    • Biological: Rhinovirus
  • Placebo Comparator: Placebo
    Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
    Interventions:
    • Dietary Supplement: Placebo
    • Biological: Rhinovirus
Publications * Turner RB, Woodfolk JA, Borish L, Steinke JW, Patrie JT, Muehling LM, Lahtinen S, Lehtinen MJ. Effect of probiotic on innate inflammatory response and viral shedding in experimental rhinovirus infection - a randomised controlled trial. Benef Microbes. 2017 Apr 26;8(2):207-215. doi: 10.3920/BM2016.0160. Epub 2017 Mar 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
789
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2012)
160
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01669603
Other Study ID Numbers  ICMJE 16241
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ronald Turner, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE DuPont Nutrition and Health
Investigators  ICMJE
Principal Investigator: Ronald Turner, MD University of Virginia
PRS Account University of Virginia
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP