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

NCT03402555 | Completed Results

• 1 other identifier: EBB17GC16961
• Study Type: observational
• Target: 96
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  30 days

• An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App

  30 days

Interventions

Stool pattern OTHER

Collection of stool images

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects aged 0-24 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• ObvioHealth: collaborator

Study Sites (2)

ObvioHealth

Orlando, Florida, 32826, United States

Location

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

Related 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.

  PMID: 28360250 BACKGROUND

Results Point of Contact

• Title: Digital Project Manager
• Organization: Danone Asia Pacific Holdings

jill.wong@danone.com

82281172

Study Officials

• Parth Shah, MD

  Obvio Health

  PRINCIPAL INVESTIGATOR

• Seng Hock Quak, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: May 31, 2018
• Primary Completion: December 17, 2018
• Study Completion: March 6, 2019
• Last Updated: August 7, 2020
• Results First Posted: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (1)