Status:
COMPLETED
Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Collaborating Sponsors:
ObvioHealth
Conditions:
Healthy
Eligibility:
All Genders
Up to 24 years
Brief Summary
Collection of a panel of stool images from healthy infants/toddlers for the development of a software
Detailed Description
To collect at least 200 images per Brussels Infant and Toddler Stool Scale (BITSS) score and at least 200 images of empty (no stool) disposable diapers from healthy infants/toddlers aged 0-24 months f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 6 2019
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03402555
Start Date
May 31 2018
End Date
March 6 2019
Last Update
August 7 2020
Active Locations (2)
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1
ObvioHealth
Orlando, Florida, United States, 32826
2
National University Hospital, Singapore
Singapore, Singapore, 119074