Infant Microbiome in Diaper Rash

August 15, 2017 updated by: Kimberly-Clark Corporation

An Exploratory Study to Evaluate the Microbial Consortia of Infants (9-12 Months) Experiencing Diaper Rash and When Healthy

The objective of this study is to evaluate the microbiome composition of infant's (9-12 month) skin experiencing diaper rash in order to determine if the onset and severity of erythema associated with diaper rash is influenced by the type of bacteria colonizing the skin.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68522
        • Midwest Children's Health Research Institute

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

9 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample of male and female infants with mild to moderate diaper rash

Description

Inclusion Criteria:

  • Infants aged 9-12 months with mild to moderate diaper rash

Exclusion Criteria:

  • Use of topical or oral antibiotics or antifungals within the past 4 weeks.
  • Use of zinc-containing diaper rash creams within 48 hours first sample
  • Immunocompromised

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operational Taxonomic Units (OTUs) of microbes present on skin
Time Frame: Change from Baseline at Day 14
Change from Baseline at Day 14
Relative abundance of microbes present on skin measured in picograms of DNA
Time Frame: Change from Baseline at Day 14
Change from Baseline at Day 14

Collaborators and Investigators

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

Sponsor

Kimberly-Clark Corporation

Investigators

  • Principal Investigator: Sahra Niazi, MD, Midwest Children's Health Research Institute

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

September 1, 2016

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

January 4, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 8, 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

  • 500-16-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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