Infant Fecal Insult Study

August 15, 2017 updated by: Kimberly-Clark Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Irving, Texas, United States, 75062
        • Reliance Clinical Testing Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 7 days
Relative abundance of microbes present on skin measured in picograms of DNA
Time Frame: up to 7 days
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kimberly-Clark Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

January 26, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

December 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 500-16-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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