InfantPopodataNCT07745413
A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France
An observational study of Infant, run by Nutricia Research.
Trial 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 more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: French infants with an age between 0-6 months
Who may be able to join
- French infants with an age between 0-6 months
Who cannot join
- Non-French infants • Infants > 6 months of age
About this study
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)
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.
- Conditions
- Infant
- Keywords
- Infants, stool consistency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| French infants | Cross sectional cohort of infants in France |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745413
- Sponsor's protocol ID
- 25REX0086705
- Acronym
- Popodata
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: \[Popodata does not use sites, it is 100% online\]
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07745413
- Acronym / sponsor ID
- Popodata / 25REX0086705
- Conditions
- Infant
- Keywords
- Infants, stool consistency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| French infants | – | –Cross sectional cohort of infants in France |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- French infants with an age between 0-6 months
Key inclusion criteria (1 listed)
- French infants with an age between 0-6 months
Key exclusion criteria (1 listed)
- Non-French infants • Infants > 6 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of infant stool consistency scores in France (BITSS).
Time frame: 1-3 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No. [Popodata does not use sites, it is 100% online]
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, run by Nutricia Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of infant stool consistency scores in France (BITSS). (time frame: 1-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.