Infant Fecal Insult Study
Sponsor
Kimberly-Clark Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02979210
Collaborator
(none)
24
1
1
3
7.9
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants
Study Start Date
:
Nov 1, 2016
Actual Primary Completion Date
:
Jan 26, 2017
Actual Study Completion Date
:
Feb 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
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
Other: Phosphate Buffered Saline
200 microliters of phosphate buffered saline
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reliance Clinical Testing Service | Irving | Texas | United States | 75062 |
Sponsors and Collaborators
- Kimberly-Clark Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:
NCT02979210
Other Study ID Numbers:
- 500-16-0003
First Posted:
Dec 1, 2016
Last Update Posted:
Aug 18, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: