Infant Microbiome in Diaper Rash

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02893501

Enrollment

Registered

2016-09-08

Start date

2016-09-30

Completion date

2017-01-04

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

Diaper Rash

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to 12 Months

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results