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

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Nutricia

Status

Not yet enrolling

Conditions

Infant

Study type

Observational

Funder types

Industry

Identifiers

NCT07745413
25REX0086705

Details and patient eligibility

About

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

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

Under 6 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • French infants with an age between 0-6 months

Exclusion criteria

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

Trial design

600 participants in 1 patient group

French infants
Description:
Cross sectional cohort of infants in France

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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