This trial is being designed to maximize caregiver compliance and minimize inconvenience by using a combination of digital instruments and expert rating.
To assess the GI tolerability of different combinations of infant formula ingredients.
Participants will be segmented into different treatment arms and assigned varying concentrations of a specialized product. Over the course of several weeks, caregivers will utilize the ObvioHealth app’s guided image capture feature to take high-quality images of stools in their babies’ diapers and submit them to the rating portal for grading by two GI physicians.
Caregivers will also collect baby stools for analysis. These samples will be collected from their homes to minimize participant inconvenience. Caregivers will complete electronic daily logs of their infant’s general health, as well as stool observations. The data collected will determine which product variations are most tolerable and efficacious for infants.
ObvioHealth’s COACH team of virtual site clinicians will monitor data submission and patient engagement throughout the study to ensure streamlined processes and participant safety.