BM Characterization Pilot

Diaper Rash Clinical Trial

Official title:

Comparison of Fecal Digestive Enzymes in Infant Aged Between 0-1 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138057
• Other study ID #: 500-17-02
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: January 16, 2018
• Start date: May 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Infants aged 0-12 months

Exclusion Criteria:

• Formula Fed

• Use of topical or oral antibiotics or antifungals within the past 4 weeks

Related Conditions & MeSH terms

• Diaper Rash

Locations

Country	Name	City	State
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine enzymes in infant stools	enzyme levels and activity of infant stools	approximately 1 week