ClinicalTrials.gg
CompletedNCT03138057Updated Jan 18, 2018

BM Characterization Pilot

An observational study in Diaper Rash, sponsored by Kimberly-Clark Corporation. Completed at 1 site in United States. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Kimberly-Clark Corporation · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
25
Ages
Up to 12 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Diaper Rash with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Diaper Rash · United States.

Started
2017
the only one that year
Observational
3 of 12
none open now
Registered
6th of 12
by date
Lead sponsor
3 of 12
Kimberly-Clark Corporation

Among the 12 studies in Diaper Rash with a site in United States, this one is the only one that started in 2017, is one of 3 observational ones, and was the 6th registered.

Diaper Rash

38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.

Browse Diaper Rash studies →

Open to participants now

1 of the 12 studies in Diaper Rash with a site in United States is open now, in 1 country. Each count lists the studies.

Who these studies take

Of the 2 Diaper Rash studies recruiting now, 1 (50%) set no upper age limit and 1 (50%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.

This study: Up to 12 Months · all sexes · healthy volunteers too.

The full table on the hub →
Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Diaper Rash with a site in United States, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Diaper Rash

Browse trials for

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infants aged 0-12 months

Exclusion criteria

Exclusion Criteria:

  • Formula Fed
  • Use of topical or oral antibiotics or antifungals within the past 4 weeks
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To determine enzymes in infant stools

    enzyme levels and activity of infant stools

    Time frame: approximately 1 week

07

Study locations

1 site
  • Midwest Children's Health Research Institute
    Lincoln, Nebraska 68505, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Jun 2017, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2017
First posted
May 3, 2017
StartActual
May 1, 2017
Primary completionActual
Jun 12, 2017
CompletionActual
Dec 31, 2017
Last update
Jan 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03138057
Lead sponsor
Kimberly-Clark Corporation
Responsible party
Sponsor
First posted
May 3, 2017
Start date
May 1, 2017
Primary completion
Jun 12, 2017
Completion
Dec 31, 2017
Last update
Jan 18, 2018

Study contacts

Amy Bargen, MD
principal investigator · Midwest Children's Health Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion