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



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:8/19/2018
Start Date:May 31, 2018
End Date:December 2018
Contact:Jill Wong
Email:jill.wong@danone.com
Phone:+6582281172

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

To observe the stool patterns of healthy infants/toddlers by collecting a panel of stool
images for the development of a software

To collect 200 images of per BITTS scale score to observe the stool pattern of healthy
infants/toddlers aged 0-24 months to develop a software

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
We found this trial at
2
sites
Orlando, Florida 32826
Principal Investigator: Parth Shah, MD
Phone: 877-620-6023
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mi
from
Orlando, FL
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Singapore, 11907
Principal Investigator: Seng Hock Quak, MD
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mi
from
Singapore,
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