Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software

Completed

Conditions studied: Healthy

In brief

Collection of a panel of stool images from healthy infants/toddlers for the development of a software

Key facts

Study ID

NCT03402555

Run by

Danone Asia Pacific Holdings Pte, Ltd.

People needed

96

Starts

2018-05-31

Expected to finish

2019-03-06

Last updated by the study team

2020-08-07

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ObvioHealth — Orlando, Florida, United States
• National University Hospital, Singapore — Singapore, Singapore

Full record on ClinicalTrials.gov

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