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

Healthy Clinical Trial

— Poobao  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402555
• Other study ID #: EBB17GC16961
• Status: Completed
• Start date: May 31, 2018
• Est. completion date: March 6, 2019

Study information

• Verified date: August 2020
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 6, 2019
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Stool pattern
Collection of stool images

Locations

Country	Name	City	State
Singapore	National University Hospital, Singapore	Singapore
United States	ObvioHealth	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	ObvioHealth

Countries where clinical trial is conducted

United States,  Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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