Infant Microbiome in Diaper Rash

NCT ID: NCT02893501

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diaper Rash

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

9 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kimberly-Clark Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sahra Niazi, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Children's Health Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19892944 (View on PubMed)

Le 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.

Reference Type BACKGROUND
PMID: 26020560 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 25282569 (View on PubMed)

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. doi: 10.1111/j.1525-1470.2007.00499.x.

Reference Type BACKGROUND
PMID: 17958792 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

500-16-0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.