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

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

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Key information

Conditions

Infant

Age range

0 month–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

French infants with an age between 0-6 months

Exclusion criteria

Non-French infants • Infants > 6 months of age

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study title

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)

Acronym: Popodata

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 4, 2026
Registry last updated: Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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