Back to resultsRudolph: Nasal Microbiota With Red and Sore Nose
Primary Purpose
Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Rhinovirus Challenge
Sponsored by
About this trial
This is an interventional basic science trial for Dermatitis
Eligibility Criteria
Inclusion Criteria:
- self reported proneness to developing symptoms of nose redness and/or soreness
- sero-negative to HRV-16 at screening
Exclusion Criteria:
- confirmed or self-reported allergic rhinitis
- history of nasal or otologic surgery
- use of anti-inflammatory medication, recent antibiotics or anti-histamines
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Rhinovirus Challenge
Arm Description
Challenge with HRV-16
Outcomes
Primary Outcome Measures
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
Taxonomic classification of bacterial strains before and after HRV-16 virus for subjects with a VAS score rating >37mm
Secondary Outcome Measures
Full Information
NCT ID
NCT03073837
First Posted
February 21, 2017
Last Updated
August 15, 2017
Sponsor
Kimberly-Clark Corporation
Collaborators
NIZO Food Research, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT03073837
Brief Title
Rudolph: Nasal Microbiota With Red and Sore Nose
Official Title
RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kimberly-Clark Corporation
Collaborators
NIZO Food Research, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rhinovirus Challenge
Arm Type
Other
Arm Description
Challenge with HRV-16
Intervention Type
Other
Intervention Name(s)
Rhinovirus Challenge
Intervention Description
Challenge with HRV-16 virus
Primary Outcome Measure Information:
Title
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
Description
Taxonomic classification of bacterial strains before and after HRV-16 virus for subjects with a VAS score rating >37mm
Time Frame
change from baseline compared to day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
self reported proneness to developing symptoms of nose redness and/or soreness
sero-negative to HRV-16 at screening
Exclusion Criteria:
confirmed or self-reported allergic rhinitis
history of nasal or otologic surgery
use of anti-inflammatory medication, recent antibiotics or anti-histamines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lutter Rene, PhD
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Rudolph: Nasal Microbiota With Red and Sore Nose
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