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  • “A pilot study to assess the safety, tolerability and efficacy of virtual reality for the treatment of gastroparesis” Jacksonville, Fla.

    We hypothesize that patients with gastroparesis (GP) who use regular sessions of active virtual reality (VR) will experience a greater reduction in global symptoms of gastroparesis, as measured by a reduction in symptom scores using the Gastroparesis Cardinal Symptom Index (GCSI), the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM), a visual analog scale for nausea (VAS) and a numerical rating scale for abdominal pain (NRS), compared to patients with GP treated with sham VR therapy.    This pragmatic trial is a pilot study to assess the safety, tolerability and efficacy of virtual reality for the treatment of gastroparesis.

    There are three main aims for this study. One, to determine whether VR is safe for the treatment of GP. Two, to determine whether using VR therapy is tolerable for the treatment of GP symptoms. Three, to determine whether VR is an effective treatment for symptoms of GP compared to sham VR therapy.  A key objective of the third aim will be to compare changes in global gastroparesis symptom scores, as measured by the GCSI, at the end of the 4-week study period compared to baseline, in patients with GP treated with active VR therapy compared to those treated with sham VR.   Secondary objectives for the third aim will be to assess changes in overall total PAGI-SYM scores, changes in individual scores for nausea (using a VAS), changes in abdominal pain using a NRS, and changes in bloating using the validated Mayo Bloating Questionnaire. Changes in work productivity will be assessed during the 4-week trial using the validated WPAI (work productivity activity index) while short-term changes in quality of life will be assessed using the Short-Form 12 questionnaire.

  • A pilot study to evaluate the efficacy and safety of virtual reality in combination with linaclotide for the treatment of adults with IBS and constipation predominance (IBSCVR) Jacksonville, Fla.

    A study to determine if adult patients with IBS-C will report an overall greater improvement in IBS quality of life when treated with a combination of linaclotide and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham VR therapy.

  • Chronic nausea and vomiting: utility of a wireless patch system (WPS) to categorize gastric sensorimotor disorders and assess response to therapy Jacksonville, Fla.

    The purpose of this study is to objectively measure gastric, small intestine and colonic motility in patients with chronic nausea and vomiting and identify patterns that help distinguish common gastric sensorimotor disorders.

  • Evaluating the Therapeutic Efficacy of Rifaximin in Patients with Diabetic Gastroparesis Using Bloating as the Primary Endpoint Jacksonville, Fla.

    The primary purpose of this study is to prospectively assess symptoms of bloating (severity, prevalence) in patients with diabetic gastroparesis.

  • Resilience in patients with Functional Dyspepsia: a prospective questionnaire study Jacksonville, Fla.

    The purpose of this stud is to determine if resilience to baseline stressors will be lower in patients with Functional Dyspepsia (FD) than the general population and comparable to patients with other disorders of gut-brain interaction, such as IBS, which frequently co-exists with FD. 

  • The Relationship Between Breath Testing Results and Pre-test Symptom Severity Using a Validated Bloating Questionnaire Jacksonville, Fla.

    We will be testing the relationship between a recently validated bloating questionnaire and breath test results to learn if the severity of self-reported bloating on the Mayo Bloating Questionnaire will correlate with the degree of positivity on fructose, lactose, and lactulose breath tests.

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