Infant Microbiome in Diaper Rash

Completed

• Conditions: Diaper Rash

• Registration Number: NCT02893501
• Lead Sponsor: Kimberly-Clark Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Midwest Children's Health Research Institute; 🇺🇸 Lincoln, Nebraska, United States