Infant Microbiome in Diaper Rash
An Exploratory Study to Evaluate the Microbial Consortia of Infants (9-12 Months) Experiencing Diaper Rash and When Healthy
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2017
CompletedAugust 18, 2017
August 1, 2017
4 months
August 29, 2016
August 15, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Eligibility Criteria
Community sample of male and female infants with mild to moderate diaper rash
You may qualify if:
- Infants aged 9-12 months with mild to moderate diaper rash
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68522, United States
Related Publications (4)
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.
PMID: 19892944BACKGROUNDLe Lamer M, Pellerin L, Reynier M, Cau L, Pendaries V, Leprince C, Mechin 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.
PMID: 26020560BACKGROUNDSakabe 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. No abstract available.
PMID: 25282569BACKGROUNDAdalat S, Wall D, Goodyear H. Diaper dermatitis-frequency and contributory factors in hospital attending children. Pediatr Dermatol. 2007 Sep-Oct;24(5):483-8. doi: 10.1111/j.1525-1470.2007.00499.x.
PMID: 17958792BACKGROUND
Biospecimen
swabs and tape strips of the diaper rash area will be analyzed
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sahra Niazi, MD
Midwest Children's Health Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 8, 2016
Study Start
September 1, 2016
Primary Completion
January 4, 2017
Study Completion
January 4, 2017
Last Updated
August 18, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share