A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France

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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07745413

Acronym

Popodata

Enrollment

600

Registered

2026-08-04

Start date

2026-08-01

Completion date

2027-06-30

Last updated

2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant

Keywords

Infants, stool consistency

Brief summary

The objective of this study is to investigate the influence of various factors (e.g. diet) on the stool consistency of infants in France.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

0 Months to 6 Months

Healthy volunteers

Yes

Inclusion criteria

* French infants with an age between 0-6 months

Exclusion criteria

* Non-French infants • Infants \> 6 months of age

Design outcomes

Primary

Measure	Time frame	Description
Distribution of infant stool consistency scores in France (BITSS).	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.

Outcome results