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Completed

NCT Number: NCT03402555

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

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

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Key information

Conditions

Healthy

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital, Singapore, Singapore

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Stool pattern

Other

Collection of stool images

Primary outcomes

  1. Total Number of Stool Images Collected

    Time frame: 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

Other outcomes

  1. A Comparison of the Stool Consistency Scores From the Mothers On-study to Re-scores From Mothers (Not Enrolled on Study) Based Only on the Uploaded Images

    Time frame: 30 days

    A comparison of the stool consistency scores from the mothers on-study to re-scores from two mothers (not enrolled on study, Mother #1 and Mother #2) based only on the uploaded images

  2. An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App

    Time frame: 30 days

    An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Collaborators

  • ObvioHealth

Registry information

Official study title

Observational Study: Image Collection of Infant/Toddler Stools for Danone Software Development

Acronym: Poobao

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 18, 2018
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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