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

The Evolution of the Skin Microbiome of Children Approximately Ages 8-10 Years of Age

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Consumer Experience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and their biological mothers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children; Children 8-10 years of age
Biological Mothers; Biological mothers of children now ages 8-10 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	swabs will be collected from the skin for analysis to determine the total number of different bacterial taxa detected	Day 1
Microbial Community Richness for Adults	swabs will be collected from the volar forearm, forehead and cheek for analysis to determine the total number of different bacterial taxa detected	Day 1
Skin Barrier Function	Trans Epidermal Water Loss (TEWL) will be used to assess the skin barrier function	Day 1
Skin pH	skin pH will be assessed by pH meter	Day 1

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Bruce L Moskovitz, MD, Bruce L Moskovitz MD - private consultant

Publications and helpful links

Helpful Links

• Redacted Clinical Study Report

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: microbiome; microflora; bacteria taxa
• Other Study ID Numbers: CCSSKA000104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No