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NCT02979210 Clinical Trial

Infant Fecal Insult Study

Dermatitis Clinical Trial

Official title:
Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02979210
Other study ID # 500-16-0003
Secondary ID
Status Completed
Phase N/A
First received November 29, 2016
Last updated August 15, 2017
Start date November 2016
Est. completion date February 1, 2017

Study information
Verified date August 2017
Source Kimberly-Clark Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 1, 2017
Est. primary completion date January 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• Phosphate Buffered Saline
200 microliters of phosphate buffered saline

Locations
Country Name City State
United States Reliance Clinical Testing Service Irving Texas

Sponsors (1)
Lead Sponsor Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5. — View Citation

Ishikawa J, Shimotoyodome Y, Ito S, Miyauchi Y, Fujimura T, Kitahara T, Hase T. Variations in the ceramide profile in different seasons and regions of the body contribute to stratum corneum functions. Arch Dermatol Res. 2013 Mar;305(2):151-62. doi: 10.1007/s00403-012-1286-5. Epub 2012 Sep 18. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Type of microbes present on skin after exposure to artificial fecal insult Microbes will be identified by metagenomic sequencing up to 7 days
Primary Relative abundance of microbes present on skin measured in picograms of DNA up to 7 days
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