Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kimberly-Clark Corporation
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Type of microbes present on skin after exposure to artificial fecal insult
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Artificial Fecal Insult
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)
Intervention: Artificial Fecal Insult (Other)
Artificial Fecal Insult
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)
Intervention: Phosphate Buffered Saline (Other)
Outcomes
Primary Outcomes
Type of microbes present on skin after exposure to artificial fecal insult
Time Frame: up to 7 days
Microbes will be identified by metagenomic sequencing
Relative abundance of microbes present on skin measured in picograms of DNA
Time Frame: up to 7 days
Secondary Outcomes
No secondary outcomes reported