Clinical trial NCT03402555: Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software
Official title: Observational Study: Image Collection of Infant/Toddler Stools for Danone Software Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ObvioHealth
First posted: 2018-01-18
Enrollment: 96
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects aged 0-24 months

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

Eligibility criteria: 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

Primary outcomes:
measure: Total Number of Stool Images Collected
timeFrame: At least 30 days
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: 30 days
measure: An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App
timeFrame: 30 days
Locations:
city: Orlando
country: United States
facility: ObvioHealth
state: Florida
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: Obvio Health
name: Parth Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Seng Hock Quak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.