Rudolph: Nasal Microbiota With Red and Sore Nose

August 15, 2017 updated by: Kimberly-Clark Corporation

RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects

This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Rhinovirus Challenge
Challenge with HRV-16
Other: Rhinovirus Challenge
Challenge with HRV-16 virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
Time Frame: change from baseline compared to day 22
Taxonomic classification of bacterial strains before and after HRV-16 virus for subjects with a VAS score rating >37mm
change from baseline compared to day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimberly-Clark Corporation

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NIZO Food Research

Investigators

  • Principal Investigator: Lutter Rene, PhD, AIDS Malignancy Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

April 18, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (Actual)

March 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 500-16-0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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