Infant Microbiome in Diaper Rash

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diaper Rash Dermatitis Dermatitis, Contact Dermatitis, Irritant Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

9 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68522, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Operational Taxonomic Units (OTUs) of microbes present on skin

Time frame: 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

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 8, 2016
Registry last updated: Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed