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Gastrointestinal Virtual Clinical Trials

Progressing GI health through better data

Approximately 60 to 70 million people are affected by a digestive disease, according to the U.S. Department of Health and Human Services. Yet there are multiple challenges in evaluating the benefit of therapeutic products for GI conditions, including small efficacy margins, large placebo effects, outcome measures overly reliant on patient reporting, and the risk of missing adverse events.

ObvioHealth’s virtual study design and user-friendly app breaks down barriers to traditional GI research. Stool samples can be collected at home and sent to a lab.

Patient reported data on taboo topics like flatulence and bowel movements is collected through the app without the need for face-to-face conversations with a physician.  This results in higher retention rates as well as more complete and better data.

See below for more on ObvioHealth’s experience in GI clinical research.  

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GI category label.Pediatrics category label.
Image Collection of Infant/ Toddler Stools for Software Development and GI Assessment

Virtual observational study using the ObvioHeath app to collect and classify images of infant stool samples and gather data representative of GI function.

• 2,366 evaluable images collected
• 95% retention
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GI category label.Nutrition category label.
Evaluating Efficacy and GI Tolerance of Inulin Fiber Bars

A fortune 500 multinational food company wanted to understand clinical efficacy, GI tolerance, and consumer perception of four iterations of its inulin fiber bar. ObvioHealth virtually recruited, randomized, shipped and captured data across 4 samples in record time.

• 85% questionnaire compliance
• 92% retention
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A mother feeding her infant formula through a bottle.
GI category label.Pediatrics category label.Nutrition category label.
Studying the Impact of Infant GI Disorders on Parents in Asia

Parents of 1000 healthy infants and toddlers completed a six-part, logic-based questionnaire to assess the prevalence and management of FGIDs, impacts on QoL, and efficacy of treatments.

• 1000 patients enrolled in less than 1 month
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The ObvioHealth App

Our proprietary application brings clinical research into people’s homes, making it easier for them to participate, and easier for researchers to collect robust data sets which reflect real behaviors.

"Stomach Gas Symptom" screen of the ObvioHealth app.
"Stomach Gas Symptom" screen of the ObvioHealth app.
"Stomach bloating" questionnaire on the ObvioHealth app.

Curious if Your GI Study Can Go Virtual?

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Delivering Better Data for Your GI Study

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Recruitment & Onboarding

Recruitment is often a huge barrier to trial success, particularly for GI studies. ObvioHealth uses digital targeting methods to find untapped populations. We identify the online behaviors that point to people with a positive pre-disposition for a specific trial and, because our studies are virtual, we are not geographically tied to a site location.  Data is collected through our proprietary app, giving participants more privacy in their responses.

Once recruited, we enroll participants through virtual prescreening/screening and e-consent. This eliminates the burdensome cost of site retention and staffing requirements, and often shortens the recruitment period.

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Outcomes Measurement

The ObvioHealth platform and app incorporates multiple data capture technologies to adapt to the needs of any given trial.  These include simple survey-type completion of questionnaires and diaries, image, video and audio capture and use of wearables. Complementary data collection methods ensure more robust data based on real world outcomes.  

Symptoms of GI disorders can be physically uncomfortable, but also quite awkward to discuss with a doctor, leading to fear of embarrassment in face to face interactions. GI study subjects are generally more willing to contribute to research, knowing they can participate from the comfort and discretion of their homes without the burden of traveling to site visits.  

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Logistics Management 

Our platform makes it easy to trigger, track and manage products and payment of incentives. ObvioHealth can reimburse participants with the stipend program that is fully virtual. We ship any needed study supplies or devices directly to the participant’s home.

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Medication Adherence & Adverse Events

An important advantage of ObvioHealth’s app is the real time remote monitoring of medication adherence and potential adverse events. Our escalating system of reminders and immediate AE/SAE detection make our studies safer, while also improving medication adherence.

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Higher compliance, higher retention, more accurate data

Our easy-to-use, convenient app makes it easier for participants to remain compliant. There is little to no time wasted travelling to clinical sites, so there are fewer drop-outs. All of this means that studies end on time or ahead of schedule. And because participants are able to report more real world and real time experiences, the resulting data is more accurate and reliable.