Infant Fecal Insult Study

Kimberly-Clark Corporation24 enrolled

Overview

The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Dermatitis

Interventions

Artificial Fecal InsultOTHER

protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline

Phosphate Buffered SalineOTHER

200 microliters of phosphate buffered saline

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Subjects with Fitzpatrick Skin Types I, II or III Exclusion Criteria: * Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

Locations (1)

Reliance Clinical Testing Service

Irving, Texas, United States

Outcomes

Primary Outcomes

Type of microbes present on skin after exposure to artificial fecal insult

Microbes will be identified by metagenomic sequencing

Time frame: up to 7 days

Relative abundance of microbes present on skin measured in picograms of DNA

Time frame: up to 7 days

Data from ClinicalTrials.gov

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