Diaper RashNCT03138057
BM Characterization Pilot
An observational study of Diaper Rash, run by Kimberly-Clark Corporation at 1 site in United States.
Trial summary
This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages. Read more about this study
- Who is it for?
- Ages Up 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
- 1 May 2017to 31 Dec 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample of male and female infants who are not formula fed
Who may be able to join
- Infants aged 0-12 months
Who cannot join
- Formula Fed
- Use of topical or oral antibiotics or antifungals within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68505
About this study
Official title: Comparison of Fecal Digestive Enzymes in Infant Aged Between 0-1 Years Old
This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.
- 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.
To determine enzymes in infant stools
enzyme levels and activity of infant stools
Measured: approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 May 2017
- Primary completion12 Jun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Amy Bargen, MD, Principal investigator, Midwest Children's Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138057
- Sponsor's protocol ID
- 500-17-02
- Status last verified
- Jan 2018
- First submitted
- 20 Apr 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fecal Digestive Enzymes in Infant Aged Between 0-1 Years Old
- ClinicalTrials.gov ID
- NCT03138057
- Acronym / sponsor ID
- 500-17-02
- Conditions
- Diaper Rash
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 May 2017 (actual)
- 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.
This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample of male and female infants who are not formula fed
Key inclusion criteria (1 listed)
- Infants aged 0-12 months
Key exclusion criteria (2 listed)
- Formula Fed
- Use of topical or oral antibiotics or antifungals within the past 4 weeks
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
To determine enzymes in infant stools
Time frame: approximately 1 week
enzyme levels and activity of infant stools
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 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Diaper Rash
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Diaper Dermatitis
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis
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.
Amy Bargen, 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 2 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 Jan 2018. 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?
To determine enzymes in infant stools (time frame: approximately 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2018.