Brian E. Lacy, M.D.

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 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.

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

The purpose of this study is to treat symptoms of IBS with diarrhea using combination therapy of a low-FODMAP diet and a neuromodulator.

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 purpose of this study is to assess differences in acoustic, prosodic, and temporal voice features between patients with and without gastroesophageal reflux (GER) symptoms. To achieve this aim, we will study the differences in voice between patients with and without GER symptoms. Evaluate differences in acoustic, prosodic, and temporal voice features between individuals with GER before and after treatment with proton pump inhibitor (PPI) therapy. To achieve this, we will compare patients’ voice features at baseline and both 4- and 8-weeks after the initiation of acid suppression therapy. At minimum, patients will be instructed to take a standard, once-daily dose of a PPI. Patients will be asked to not significantly change their diet or other medications during this time period. Assess whether individuals with known Barrett’s esophagus exhibit unique acoustic, prosodic, and temporal voice features when compared to GER patients and healthy controls. To achieve this aim, we will study the differences in voice between patients with and without known Barrett’s esophagus. Evaluate whether the vocal profiles of patients with Barrett’s esophagus remain stable during ongoing PPI therapy over 8 weeks. To achieve this, we will compare patients’ voice features at baseline and both 4- and 8-weeks after the initiation of acid suppression therapy. At minimum, patients will be instructed to take a standard, once-daily dose of a PPI. Patients will be asked to not significantly change their diet or other medications during this time period.

The purpose of this study is to assess the prevalence of Avoidant/Restrictive Food Intake Disorder (ARFID) in patients with Rome IV Functional Dyspepsia (FD).

The purpose of this study is to demonstrate the safety and effiectiveness of Aluvra for the treatment of GERD.

The purpose of this study is to assess the effectiveness and safety of treatment with various dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

The purpose of this study is to evaluate the effectiveness and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).

The purpose of this study is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients.  

The purpose of this study is to evaluate abdominal pain response to BOS-589 in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) after 4 weeks of treatment, and to evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo (PBO).

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.

The purpose of this study is to objectively measure gastric motility during a standardized test meal, and over the full course of the WPS test, identify patients with delayed gastric emptying as accurately as a scintigraphic gastric emptying scan.

This study will see if a new wireless patch system (WPS) will be able 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

The purpose of this study is to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.

The purpose of this study is to evaluate symptom response to a low FODMAP diet provided by different educational programs, assess adherence to the low FODMAP diet provided by different educational programs, and to measure knowledge retention for different low FODMAP educational programs.

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.