Infant Fecal Insult Study
Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 18, 2017
August 1, 2017
3 months
November 29, 2016
August 15, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Type of microbes present on skin after exposure to artificial fecal insult
Microbes will be identified by metagenomic sequencing
up to 7 days
Relative abundance of microbes present on skin measured in picograms of DNA
up to 7 days
Study Arms (1)
Artificial Fecal Insult
OTHERprotease/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)
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthy Subjects with Fitzpatrick Skin Types I, II or III
You may not qualify if:
- Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reliance Clinical Testing Service
Irving, Texas, 75062, United States
Related 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.
PMID: 19892944BACKGROUNDIshikawa 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.
PMID: 22987221BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 1, 2016
Study Start
November 1, 2016
Primary Completion
January 26, 2017
Study Completion
February 1, 2017
Last Updated
August 18, 2017
Record last verified: 2017-08