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

N/ANot Yet RecruitingNCT07745413

Nutricia Research600 enrolled

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.

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

600

Conditions

Infant

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * French infants with an age between 0-6 months Exclusion Criteria: * Non-French infants • Infants \> 6 months of age

Outcomes

Primary Outcomes

Distribution of infant stool consistency scores in France (BITSS).

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.

Time frame: 1-3 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.