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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Stool pattern

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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital, Singapore
• United States
  • Florida
    • Orlando, Florida, United States, 32826
      • ObvioHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects aged 0-24 months

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Stool Images Collected	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	At least 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 days
An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App	An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire	30 days

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: ObvioHealth
• Investigators: Principal Investigator: Parth Shah, MD, Obvio Health; Principal Investigator: Seng Hock Quak, MD, National University Hospital, Singapore

Publications and helpful links

General Publications

• Vandenplas Y, Szajewska H, Benninga M, Di Lorenzo C, Dupont C, Faure C, Miqdadi M, Osatakul S, Ribes-Konickx C, Saps M, Shamir R, Staiano A; BITSS Study Group. Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study. BMJ Open. 2017 Mar 29;7(3):e014620. doi: 10.1136/bmjopen-2016-014620.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2018
• Primary Completion (ACTUAL): December 17, 2018
• Study Completion (ACTUAL): March 6, 2019

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EBB17GC16961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No