A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France (Popodata)
July 30, 2026 updated by: Nutricia Research
A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France Using the Stool Tracker (an Image Recognition AI for Automated Stool Consistency Detection)
The objective of this study is to investigate the influence of various factors (e.g.
diet) on the stool consistency of infants in France.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
The main objective of this study is to investigate the distribution of infant stool consistency in France in a real-world context and assess variables that are potentially associated with stool consistency.
The study will involve real-world data collection via a survey.
Caregiver(s) are approached/reached via social media.
Caregiver(s) enter retrospective (e.g., demographics, feeding history) and current data (e.g., diet, health status), along with uploading data and images on their infant's stool.
Caregivers can upload data and images as often as they want to, until their infant reaches the age of 6 months.
Stool consistency will evaluated both via parent reported BITSS as well as via the Stool Tracker AI module.
Study Type
Observational
Enrollment (Estimated)
600
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
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
French infants with an age between 0-6 months
Description
Inclusion Criteria:
- French infants with an age between 0-6 months
Exclusion Criteria:
- Non-French infants • Infants > 6 months of age
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
Cohorts and Interventions
Group / Cohort |
|---|
|
French infants
Cross sectional cohort of infants in France
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distribution of infant stool consistency scores in France (BITSS).
Time Frame: 1-3 days
|
Assessment of the association between different factors/variables and stool consistency scores, including demographics, diet/feeding history (exclusively breast-fed, formula-fed, mixed-fed), infant formula type, recent antibiotic use amongst others.
|
1-3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
August 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
July 30, 2026
First Submitted That Met QC Criteria
July 30, 2026
First Posted (Actual)
August 4, 2026
Study Record Updates
Last Update Posted (Actual)
August 4, 2026
Last Update Submitted That Met QC Criteria
July 30, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 25REX0086705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
[Popodata does not use sites, it is 100% online]
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.