NCT03138057

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

April 20, 2017

Last Update Submit

January 16, 2018

Conditions

Diaper Rash

Outcome Measures

Primary Outcomes (1)

  • To determine enzymes in infant stools

    enzyme levels and activity of infant stools

    approximately 1 week

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community sample of male and female infants who are not formula fed

You may qualify if:

  • Infants aged 0-12 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68505, United States

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Amy Bargen, MD

    Midwest Children's Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

May 3, 2017

Study Start

May 1, 2017

Primary Completion

June 12, 2017

Study Completion

December 31, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)