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.
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.
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.
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.
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.
To assess the GI tolerability of different combinations of infant formula ingredients.
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.
To assess the GI tolerability of different combinations of infant formula ingredients.
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.
ObvioHealth successfully conducted a clinical trial for RedHill Biopharma to test the safety and efficacy of an oral medication for the treatment of COVID-19 symptoms. We designed this decentralized study to be conducted where the majority of patients recover from illness—in their homes. When the trial was launched in 2021, its unique combination of home health visits, electronic patient-reported outcomes (ePRO), and remote monitoring devices was pioneering—COVID-19 studies were typically conducted inside hospitals.
ObvioHealth and Renovia conducted a groundbreaking study on the efficacy of an at-home medical device for the treatment of stress and mixed urinary incontinence. Read more below to understand how we delivered a successful, fully virtual clinical trial in the midst of the pandemic.