To evaluate colic symptoms in breastfed infants who’ve consumed a specialized probiotic containing a sub-species group of bacteria once heavily present in the human gut.
This 3-week decentralized, randomized, placebo-controlled study will enroll mothers of 120 infants who self-report 3+ hours of crying per day (7-day period). Mothers will utilize an audio recording device paired with the ObvioHealth App to complete screening.
Once randomized, the study product will be cold shipped overnight for immediate storage. Mothers will report the frequency and duration of crying via eDiary and record and upload audio samples via the app. Stool swabs and samples are to be collected daily (15 days, including baseline and treatment period) and stored in a home freezer within a provisioned container. Upon study completion, a COACH team member will schedule a convenient time for a courier to retrieve the samples.
Throughout the study, the COACH staff will monitor reported changes to the infant’s health status and assess eDiary data in real-time for potential AE/SAE.
This study utilizes patient-centric decentralized methodologies to ease participant burden while ensuring their safety.
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