Infant Fecal Insult Study
Not Applicable
Completed
- Conditions
- Dermatitis
- Interventions
- Other: Artificial Fecal InsultOther: Phosphate Buffered Saline
- Registration Number
- NCT02979210
- Lead Sponsor
- Kimberly-Clark Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Artificial Fecal Insult Phosphate Buffered Saline 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) Artificial Fecal Insult 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)
- Primary Outcome Measures
Name Time Method Type of microbes present on skin after exposure to artificial fecal insult up to 7 days Microbes will be identified by metagenomic sequencing
Relative abundance of microbes present on skin measured in picograms of DNA up to 7 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Reliance Clinical Testing Service
🇺🇸Irving, Texas, United States