Diaper RashNCT02893501
Infant Microbiome in Diaper Rash
An observational study of Diaper Rash, run by Kimberly-Clark Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Diaper Rash
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 4 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample of male and female infants with mild to moderate diaper rash
Who may be able to join
- Infants aged 9-12 months with mild to moderate diaper rash
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68522
About this study
Official title: An Exploratory Study to Evaluate the Microbial Consortia of Infants (9-12 Months) Experiencing Diaper Rash and When Healthy
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.
- Conditions
- Diaper Rash
- Medical subject headings
- Diaper Rash
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational Taxonomic Units (OTUs) of microbes present on skin
Measured: Change from Baseline at Day 14
Relative abundance of microbes present on skin measured in picograms of DNA
Measured: Change from Baseline at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sahra Niazi, MD, Principal investigator, Midwest Children's Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893501
- Sponsor's protocol ID
- 500-16-0002
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19892944Le 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.
PubMed 26020560Sakabe 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.
PubMed 25282569Adalat 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.
PubMed 17958792
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Microbial Consortia of Infants (9-12 Months) Experiencing Diaper Rash and When Healthy
- ClinicalTrials.gov ID
- NCT02893501
- Acronym / sponsor ID
- 500-16-0002
- Conditions
- Diaper Rash
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample of male and female infants with mild to moderate diaper rash
Key inclusion criteria (1 listed)
- Infants aged 9-12 months with mild to moderate diaper rash
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Background: PubMed 19892944Costello 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.
- Background: PubMed 26020560Le 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.
- Background: PubMed 25282569Sakabe 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.
- Background: PubMed 17958792Adalat 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.
- Individual participant dataSharing planned: No
Related trials for Diaper Rash
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahra Niazi, MD principal investigator
Midwest Children's Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaper Rash, run by Kimberly-Clark Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operational Taxonomic Units (OTUs) of microbes present on skin (time frame: Change from Baseline at Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893501, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.