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

Danone

Status: Completed

Conditions: Healthy

Treatments: Other: Stool pattern

Study type: Observational

Funder types: Industry

Identifiers

NCT03402555

EBB17GC16961

Details and patient eligibility

About

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

Full 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 for the development of a software

Enrollment: 96 patients

Sex: All

Ages: Under 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy infants/toddlers (0-24 months of age at time of enrollment)
2. Informed consent from mother ≥21 years of age
3. 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
4. Infant/toddler consumes standard, age-appropriate food (breast milk; formula; commercial/homemade baby, table or finger food)
5. 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:

1. The use of cloth diapers (mothers must commit to using disposable diapers for the duration of the study)
2. Known to have a significant condition (including during pregnancy) that might interfere with the study compliance, as per PI's clinical judgment
3. Deemed likely to be non-compliant with the study protocol, as per PI's clinical judgment

Trial design