NCT01669603

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
789

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3.8 years

First QC Date

August 16, 2012

Results QC Date

March 8, 2017

Last Update Submit

April 20, 2017

Conditions

Common Cold

Keywords

Common cold

Outcome Measures

Primary Outcomes (1)

  • Interleukin-8 (IL-8)

    Nasal lavage will be performed to collect and measure IL-8.

    72 hours

Study Arms (2)

Bifidobacterium animalis lactis Bl-04

EXPERIMENTAL

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

Dietary Supplement: Bifidobacterium lactis Bl-04Biological: Rhinovirus

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: PlaceboBiological: Rhinovirus

Interventions

Bifidobacterium lactis Bl-04DIETARY_SUPPLEMENT

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

Bifidobacterium animalis lactis Bl-04
PlaceboDIETARY_SUPPLEMENT

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

Placebo
RhinovirusBIOLOGICAL

rhinovirus for experimental challenge

Bifidobacterium animalis lactis Bl-04Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two weeks prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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.

    PMID: 28343401DERIVED

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Ronald Turner
Organization
University of Virginia
rbt2n@virginia.edu

Study Officials

  • Ronald Turner, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 21, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 25, 2017

Results First Posted

April 25, 2017

Record last verified: 2017-04

Locations

US(1)