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

Completed

• Conditions: Healthy

• Registration Number: NCT03402555
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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 for the development of a software

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Study Start: 2018-05-31
• Primary Completion: 2018-12-17
• Study Completion: 2019-03-06
• Results First Submitted: 2020-06-24
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Results First Posted: 2020-08-07
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Number of Stool Images Collected	At least 30 days	Creation of a database containing at least 1600 pictures of individual diapers: * 200 images of diapers with stool per each score (BITSS types 1 to 7); * 200 images of empty (no stool) disposable diapers

Trial Locations

Locations (2)

ObvioHealth; 🇺🇸 Orlando, Florida, United States

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore