Rudolph: Nasal Microbiota With Red and Sore Nose

NCT ID: NCT03073837

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-08-15

Brief Summary

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

Detailed Description

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Conditions

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Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rhinovirus Challenge

Challenge with HRV-16

Group Type OTHER

Rhinovirus Challenge

Intervention Type OTHER

Challenge with HRV-16 virus

Interventions

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Rhinovirus Challenge

Challenge with HRV-16 virus

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NIZO Food Research

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Kimberly-Clark Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lutter Rene, PhD

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Locations

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Academic Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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500-16-0006

Identifier Type: -

Identifier Source: org_study_id

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