N/A
N=96
Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03402555 ↗Enrolled (actual)
96
Serious AEs
—
Results posted
Aug 2020
Primary outcome: Primary: Total Number of Stool Images Collected — 2731 images
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Stool pattern (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Stool Images Collected |
2731 | — |
Summary
Collection of a panel of stool images from healthy infants/toddlers for the development of a software
Eligibility Criteria
Inclusion Criteria
- Healthy infants/toddlers (0-24 months of age at time of enrollment)
- Informed consent from mother ≥21 years of age
- In-home access to reliable internet connections; a mobile device suitable for electronic communication; and a device suitable for capturing and transmitting high-quality electronic images as per the PI's discretion
- Infant/toddler consumes standard, age-appropriate food (breast milk; formula; commercial/homemade baby, table or finger food)
- Based on the number of stools already acquired per relevant strata at time of enrollment, infant/toddler may or may not be required to regularly produce stools scored as a Score 1, 2, 6 or 7
Exclusion Criteria
Mothers of Infants/Toddlers:
- The use of cloth diapers (mothers must commit to using disposable diapers for the duration of the study)
- Known to have a significant condition (including during pregnancy) that might interfere with the study compliance, as per PI's clinical judgment
- Deemed likely to be non-compliant with the study protocol, as per PI's clinical judgment
Data sourced from ClinicalTrials.gov (NCT03402555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.