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

NCT ID: NCT01669603

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 789 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-06-30

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Bifidobacterium animalis lactis Bl-04

Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.

Group Type: EXPERIMENTAL

Bifidobacterium lactis Bl-04

Intervention Type: DIETARY_SUPPLEMENT

The study product will be a 2\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.

Rhinovirus

Intervention Type: BIOLOGICAL

rhinovirus for experimental challenge

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Rhinovirus

Intervention Type: BIOLOGICAL

rhinovirus for experimental challenge

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Rhinovirus

rhinovirus for experimental challenge

Intervention Type: BIOLOGICAL

Eligibility 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.

• 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

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DuPont Nutrition and Health

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Ronald Turner, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald Turner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28343401 (View on PubMed)

Other Identifiers

16241

Identifier Type: -

Identifier Source: org_study_id