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Not yet recruitingNCT07745413PopodataUpdated Aug 4, 2026

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

An observational study in Infant, sponsored by Nutricia Research. Not yet recruiting. Open to participants aged 0 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Nutricia Research (part of Danone) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
600
Ages
0 Months to 6 Months
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Infant

Keywords

  • Infants, stool consistency
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In context

Lead sponsor

Nutricia Research is the lead sponsor of 51 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

French infants with an age between 0-6 months

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • French infants with an age between 0-6 months

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • French infants

    Cross sectional cohort of infants in France

06

What researchers measure

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.

    Time frame: 1-3 days

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — [Popodata does not use sites, it is 100% online]

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07745413
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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