Back to resultsInfant Fecal Insult Study
Primary Purpose
Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial Fecal Insult
Phosphate Buffered Saline
Sponsored by
About this trial
This is an interventional basic science trial for Dermatitis
Eligibility Criteria
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
Sites / Locations
- Reliance Clinical Testing Service
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Artificial Fecal Insult
Arm Description
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)
Outcomes
Primary Outcome Measures
Type of microbes present on skin after exposure to artificial fecal insult
Microbes will be identified by metagenomic sequencing
Relative abundance of microbes present on skin measured in picograms of DNA
Secondary Outcome Measures
Full Information
NCT ID
NCT02979210
First Posted
November 29, 2016
Last Updated
August 15, 2017
Sponsor
Kimberly-Clark Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02979210
Brief Title
Infant Fecal Insult Study
Official Title
Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 26, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kimberly-Clark Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artificial Fecal Insult
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Artificial Fecal Insult
Intervention Description
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 Type
Other
Intervention Name(s)
Phosphate Buffered Saline
Intervention Description
200 microliters of phosphate buffered saline
Primary Outcome Measure Information:
Title
Type of microbes present on skin after exposure to artificial fecal insult
Description
Microbes will be identified by metagenomic sequencing
Time Frame
up to 7 days
Title
Relative abundance of microbes present on skin measured in picograms of DNA
Time Frame
up to 7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Reliance Clinical Testing Service
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19892944
Citation
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.
Results Reference
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PubMed Identifier
22987221
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.
Results Reference
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Learn more about this trial
Infant Fecal Insult Study
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