Infant Fecal Insult Study

NCT ID: NCT02979210

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-01

Brief Summary

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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

Detailed Description

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Conditions

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Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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)

Group Type OTHER

Artificial Fecal Insult

Intervention Type 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

Intervention Type OTHER

200 microliters of phosphate buffered saline

Interventions

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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

Intervention Type OTHER

Phosphate Buffered Saline

200 microliters of phosphate buffered saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kimberly-Clark Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reliance Clinical Testing Service

Irving, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19892944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22987221 (View on PubMed)

Other Identifiers

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500-16-0003

Identifier Type: -

Identifier Source: org_study_id

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