Infant Microbiome in Diaper Rash

Diaper Rash Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893501
• Other study ID #: 500-16-0002
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: August 15, 2017
• Start date: September 2016
• Est. completion date: January 4, 2017

Study information

• Verified date: August 2017
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 4, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Diaper Rash

Locations

Country	Name	City	State
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Adalat S, Wall D, Goodyear H. Diaper dermatitis-frequency and contributory factors in hospital attending children. Pediatr Dermatol. 2007 Sep-Oct;24(5):483-8. — View Citation

Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5. — View Citation

Le Lamer M, Pellerin L, Reynier M, Cau L, Pendaries V, Leprince C, Méchin MC, Serre G, Paul C, Simon M. Defects of corneocyte structural proteins and epidermal barrier in atopic dermatitis. Biol Chem. 2015 Nov;396(11):1163-79. doi: 10.1515/hsz-2015-0141. Review. Erratum in: Biol Chem. 2016 Apr;397(4):381. — View Citation

Sakabe J, Kamiya K, Yamaguchi H, Ikeya S, Suzuki T, Aoshima M, Tatsuno K, Fujiyama T, Suzuki M, Yatagai T, Ito T, Ojima T, Tokura Y. Proteome analysis of stratum corneum from atopic dermatitis patients by hybrid quadrupole-orbitrap mass spectrometer. J Allergy Clin Immunol. 2014 Oct;134(4):957-60.e8. doi: 10.1016/j.jaci.2014.07.054. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operational Taxonomic Units (OTUs) of microbes present on skin		Change from Baseline at Day 14
Primary	Relative abundance of microbes present on skin measured in picograms of DNA		Change from Baseline at Day 14