- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03138057
BM Characterization Pilot
January 16, 2018 updated by: Kimberly-Clark Corporation
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nebraska
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Lincoln, Nebraska, United States, 68505
- Midwest Children's Health Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample of male and female infants who are not formula fed
Description
Inclusion Criteria:
- Infants aged 0-12 months
Exclusion Criteria:
- Formula Fed
- Use of topical or oral antibiotics or antifungals within the past 4 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine enzymes in infant stools
Time Frame: approximately 1 week
|
enzyme levels and activity of infant stools
|
approximately 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Bargen, MD, Midwest Children's Health Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
June 12, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
April 20, 2017
First Submitted That Met QC Criteria
April 28, 2017
First Posted (Actual)
May 3, 2017
Study Record Updates
Last Update Posted (Actual)
January 18, 2018
Last Update Submitted That Met QC Criteria
January 16, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 500-17-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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