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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02979210

Enrollment

Registered

2016-12-01

Start date

2016-11-30

Completion date

2017-02-01

Last updated

2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis

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

Interventions

OTHERArtificial 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

OTHERPhosphate Buffered Saline

200 microliters of phosphate buffered saline

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026