Pediatric Microbiome Study With Children Now Approximatel... | NCT03485755

Studies
Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.

NCT03485755

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Healthy Volunteers

Interventions

Not provided

Countries

United States

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

Mar 2019

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 12, 2018Actual

Primary Completion Date

Mar 23, 2018Actual

Completion Date

Mar 23, 2018Actual

First Submitted Date

Mar 8, 2018

First Submission Date that Met QC Criteria

Mar 26, 2018

First Posted Date

Apr 2, 2018Actual

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

Mar 22, 2019

Last Update Posted Date

Mar 26, 2019Actual

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

Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children		Children 8-10 years of age
Biological Mothers		Biological mothers of children now ages 8-10 years of age

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microbial Community Diversity for Children	Swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Microbial Community Diversity for Adults	swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index	Day 1
Microbial Community Richness for Children

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be the biological mother of a child (approximately age 8-10 years) enrolled in the study
All subjects are to have normal healthy skin and no presence of pre-existing or dormant dermatologic skin conditions;
Willing to use only the provided cleansing product during the washout time period;
Willing to refrain from topical product use on the skin for the duration of the study. Topical products that should not be used include moisturizers, lotions, sunscreens, oils, tanners;
Willing to refrain from swimming, using hot tubs, excessive sun exposure or tanning beds during the course of this study;

Exclusion Criteria:

Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer) a

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Children and their biological mothers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce L Moskovitz, MD	Bruce L Moskovitz MD - private consultant	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Consumer Experience Center		Skillman	New Jersey	08558	United States