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OpenTrials
Completed

NCT Number: NCT02979210

Infant Fecal Insult Study

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

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Key information

Conditions

Dermatitis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reliance Clinical Testing Service

Irving, Texas, 75062, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial Fecal Insult

Other

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

Other

200 microliters of phosphate buffered saline

Primary outcomes

  1. 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

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

    Time frame: up to 7 days

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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