A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infant. Basic parameters: 0 months — 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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.
Primary outcome measures
- Distribution of infant stool consistency scores in France (BITSS). [Time frame: 1-3 days]
Eligibility criteria
Inclusion criteria
- French infants with an age between 0-6 months
Exclusion criteria
- Non-French infants • Infants > 6 months of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07745413 · 25REX0086705