Infant/Toddler Stool Study

Objective

A baby nutrition client sought to create a database of stool images that could be used for internal software development purposes.

Methodology

ObvioHealth recruited 100 mothers of toddlers virtually. We developed the protocol, eCRF, prescreening and eICF.  Mothers captured images of their baby’s stools using their smart phones. They were trained to grade them using the Brussels scale.  Images were stratified into 7 stool consistency types and validated by two expert scorers.

Results

• Enrollment target was reached in 12 weeks.
• 2,366 images collected.
• The virtual study design facilitated strong  engagement resulting in a 95% retention rate.
• Expert scorers identified some biases in mothers’ scores, highlighting a tendency to over-report those within the ‘normal’ range.