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

NCT07745413 | Not Yet Recruiting

• 1 other identifier: 25REX0086705
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant

Keywords

Infants, stool consistency

Outcome Measures

Primary Outcomes (1)

• 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.

  1-3 days

Study Arms (1)

French infants

Cross sectional cohort of infants in France

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

French infants with an age between 0-6 months

You may qualify if:

• French infants with an age between 0-6 months

You may not qualify if:

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

Sponsors & Collaborators

• Nutricia Research: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share