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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-03-06

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Stool pattern

Collection of stool images

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes