NCT02893501CompletedNot Applicable
An Exploratory Study to Evaluate the Microbial Consortia of Infants (9-12 Months) Experiencing Diaper Rash and When Healthy
Kimberly-Clark Corporation1 site in 1 country25 target enrollmentStarted: September 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kimberly-Clark Corporation
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Operational Taxonomic Units (OTUs) of microbes present on skin
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 9 Months to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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