Rudolph: Nasal Microbiota With Red and Sore Nose | NCT03073837

Studies
Rudolph: Nasal Microbiota With Red and Sore Nose

NCT03073837

Sponsor

Kimberly-Clark Corporation

Status

Completed

Last Update Posted

Aug 18, 2017Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Dermatitis

Interventions

Rhinovirus Challenge

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2017Actual

Primary Completion Date

Apr 18, 2017Actual

Completion Date

Aug 15, 2017Actual

First Submitted Date

Feb 21, 2017

First Submission Date that Met QC Criteria

Mar 2, 2017

First Posted Date

Mar 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2017

Last Update Posted Date

Aug 18, 2017Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rhinovirus Challenge	Other	Challenge with HRV-16	Other: Rhinovirus Challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rhinovirus Challenge	Other	Challenge with HRV-16 virus	Rhinovirus Challenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	change from baseline compared to day 22

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lutter Rene, PhD	AIDS Malignancy Consortium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Center		Amsterdam		1105AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003872	Dermatitis

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided