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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03485755

Enrollment

Registered

2018-04-02

Start date

2018-03-12

Completion date

2018-03-23

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

microflora, microbiome, bacteria taxa

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results