Clinical Research Directory

ABVN Phase 2 - Vagal Maneuvers

The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators want to evaluate the effects of noninvasive stimulation of the auricular branch of the vagal nerve (ABVN) on vagal nerve function. The purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagally mediated compound nerve action potentials (CNAPs). This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of vagal stimulation through simple physical techniques (vagal maneuvers) in subjects with gastroparesis. \[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.\]

Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.

ABVN Phase 2 - Ear Stimulation

The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function. The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the vagus nerve on vagal nerve CNAPs and gastric hormones in healthy subjects and in subjects with gastroparesis.

Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls

This is an analytical validation observational cohort study is designed to provide evidence of: safety and reliability of Body Surface Gastric Mapping using the Gastric Alimetry System (GAS), normal reference values, and correlation of metrics with patient symptoms among healthy adults and patients diagnosed with upper abdominal motility disorders. GAS is intended to record, store, view and process gastric myoelectrical activity. This is a proprietary system consisting of multiple electrodes arranged on an array that is placed precisely over the stomach, a reader to collect the electrode measurements and a smart tablet application to track patient reported symptoms. Participants meeting inclusion and exclusion criteria will continue fasting for 30 minutes after the Gastric Alimetry System has been applied and begun measuring, eat a standard study meal within 10 minutes and remain quietly seated, reclining, for 4 hours as the GAS continues to collect data. The array is removed and the abdomen is examined for evidence of skin effects.

Different Doses of Naronapride vs. Placebo in Gastroparesis

This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.

Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve

The objective of this study is to determine if Gastric Electrical Stimulation may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.

Gastric Focused Ultrasound Stimulation

This randomized, sham-controlled crossover pilot study will evaluate whether noninvasive gastric focused ultrasound stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adults with gastroparesis or delayed gastric emptying. Participants will complete one active FUS visit and one sham-stimulation visit in randomized order, separated by at least 48 hours. At each visit, electrogastrography will be recorded before and after a standardized liquid nutritional drink, during active or sham stimulation, and during recovery. Gastrointestinal symptoms will be assessed at prespecified time points using the Total Symptom Score questionnaire.

Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2

The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.

Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms

The goal of this observational case-control study is to learn how stressful experiences, dietary habits, and blood nutrient levels are associated with gastrointestinal symptoms and symptoms of depression and anxiety in adults aged 18 to 65 years. The study will also examine whether positive psychological resources, such as hope, optimism, resilience, and self-confidence, are related to these associations. The main questions this study aims to answer are: * Are stressful experiences in childhood and recent stressful life events associated with gastrointestinal symptoms and symptoms of depression and anxiety? * Are dietary habits and blood levels of selected nutrients associated with gastrointestinal and psychological symptoms? * Do psychological resources, such as hope, optimism, resilience, and self-confidence, influence the relationships among stress, nutrition, gastrointestinal symptoms, and psychological well-being? Researchers will compare 100 participants with gastrointestinal disorders and psychological symptoms or a history of stress with 100 control participants who do not have chronic gastrointestinal symptoms and have low levels of depression and anxiety symptoms. Participants will: * Complete questionnaires about stressful experiences, dietary habits, gastrointestinal symptoms, depression and anxiety symptoms, psychological resources, and quality of life. * Have gastrointestinal sounds recorded. * Allow blood remaining from routine clinical testing performed before endoscopy to be used to measure cholesterol, vitamin B6, and vitamin C levels. No additional blood draw will be required for this study. All study assessments will be completed once at enrollment. There will be no follow-up visits, and participants will not receive or be assigned to any treatment as part of this study.

Disposable Endoscope Platform in Third Space Endoscopic Procedures

This is a prospective, single-arm unblinded study performed at a single tertiary center in the United States. All subjects will receive standard medical care and no experimental interventions are going to be performed. The procedures will be performed by Dr. Mohamed Othman, Dr. Salmaan Jawaid, Dr. Tara Keihanian, and Dr. Fares Ayoub. All patients undergoing third space endoscopic procedures including e-POEM and g-POEM, meeting study inclusion criteria will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approached individually for further discussion about the study and obtaining informed consent. The goal of this prospective, pilot trial is to demonstrate the efficacy, feasibility, safety, and clinical outcomes of third space endoscopic procedures completed using a disposable endoscope platform.

Vagus Nerve Response in Gastroparesis Patients

This study aims to characterize how vagus nerve compound action potentials (CNAPs) conduct along the vagus nerve in gastroparetic patients receiving GES therapy using a flexible, non-invasive multielectrode array (MEA).

Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Domperidone in Treating Patients With Gastrointestinal Disorders

This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.

The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM

The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.

Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients

This study investigates whether the dose of vasopressor medications (drugs that maintain blood pressure in shock) affects gastric emptying during tube feeding in the intensive care unit (ICU). Critically ill patients receiving vasopressors often develop impaired gastric motility, which reduces the effectiveness of enteral nutrition and increases the risk of aspiration. Gastric emptying will be objectively measured using bedside point-of-care ultrasound - a safe, painless imaging method - at three time points: before feeding (T0), at 1 hour (T1), and at 2 hours (T2) after restarting enteral nutrition following a 2-hour fasting period. Patients will be stratified into three groups based on norepinephrine equivalent dose (NEQ): Group 1 (no vasopressor, NEQ=0), Group 2 (low-to-moderate dose, NEQ \>0 to \<0.3 μg/kg/min), and Group 3 (high dose, NEQ ≥0.3 μg/kg/min). The primary outcome is gastric emptying rate (GER = (T0 volume - T2 volume) / 2 hours). Gastroparesis is defined as GER ≤0 mL/hour. Secondary outcomes include antrum cross-sectional area, agreement between ultrasound and aspirated gastric residual volume (Bland-Altman analysis), and enteral nutrition intolerance incidence. A subgroup analysis by shock type (septic, cardiogenic, hypovolemic, obstructive) will also be performed. The study aims to identify the vasopressor dose threshold at which gastric emptying is significantly impaired, and to support the use of bedside gastric ultrasound as an objective, non-invasive monitoring tool for enteral nutrition management in the ICU.

Body Surface Gastric Mapping in Patients on Semaglutide

Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of drugs used for glycemic control in diabetes, and for weight loss and management in obesity. It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However, the exact mechanisms are unknown. Alterations in gastric function, including myoelectrical activity, may be a likely mechanism of gastrointestinal side effects. Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction. A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric myoelectrical activity along with the development of severe bloating following the meal after 5 weeks of Ozempic use. This study will extend on this initial finding by conducting an exploratory pilot study to investigate the effects on gastric motility in patients with and without diabetes before and after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic compared to baseline.

Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis

Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction. Gastric emptying scintigraphy (GES) is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned. Current management strategies have often been found to be ineffective, largely due to an incomplete understanding of the disease's pathophysiology. There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy. Body surface gastric mapping (BSGM) using Gastric Alimetry (Alimetry Ltd., New Zealand) is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling. BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts, including patients with nausea and vomiting disorders, diabetes, delayed gastric emptying, and post-gastric surgery. Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES (43% vs 23%). Clinical application of these phenotypes has also aided in changing management decisions, which reduced healthcare utilization and associated costs. However, how GES and BSGM test results differentially influence clinical management in patients is uncertain. This exploratory pilot study proposes a two-arm, prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care (GES) in patients with suspected gastroparesis. The trial consists of two phases. Phase 1 involves participants separately undertaking a GES and BSGM test. Based on these results, the referring clinician will devise management plans for treatment using a standardized form: 1) unblinded to one test (GES or BSGM) but blinded to the other test; and 2) unblinded to both tests (GES + BSGM). They will be asked to recommend any changes to interventions (medications, diet, endoscopic/surgical referral or other) and additional testing. In phase 2, those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period. A separate set of participants will be recruited to undergo standard of care (GES only) in parallel with Phase 1 participants. After 12 months, those on the standard of care arm will be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months. Questionnaires will assess symptoms, quality of life, health psychology, sleep, and work impact. If validated, this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach.

Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes

This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.

TENS in Scleroderma

The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma. Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.

Use of Intrapyloric Botulinum Injections in Children

This study aims to evaluate the effect of intrapyloric botulinum toxin in children with feeding disorders.

Brain-Gut Yoga for Functional Dyspepsia and Gastroparesis (FD-GP)

The purpose of this research study is to assess whether using a yoga-based intervention in practice is feasible (possible) and acceptable to patients with Functional Dyspepsia and/or Gastroparesis (FD-GP).

Virtual Poetry Workshops to Enhance Patient Well Being and Reduce Anxiety

This study examines whether participating in poetry workshops can improve emotional well-being among patients with chronic digestive symptoms. Many individuals with long-standing digestive conditions experience distress, anxiety, isolation, and difficulty expressing their emotions in clinical settings. These emotional challenges can negatively affect daily life, relationships, and overall health. Poetry writing offers a creative and supportive way for participants to explore their feelings, express their experiences, and build emotional resilience. It also allows individuals to focus on aspects of their identity beyond their illness. The purpose of this research is to evaluate whether poetry workshops can reduce anxiety, lessen feelings of isolation, and strengthen participants' sense of community and well being. 1\. Why is this study being done? The purpose of this research study is to offer a creative outlet for patients to explore their identity and story, build resilience, and seek hope. This study is being done because we understand that the psychological discomfort that can come upon hearing a diagnosis can lead to increased anxiety levels, negatively impacting a patient's well-being and relationships. Often healthcare practitioners may merely view a patient through the lens of their diagnosis, neglecting other aspects of their identity and humanity. Through reading various poems, crafting their own poems, and sharing their work with their peers, we hope the workshops offer a comforting opportunity for the participants to explore their identities and creativity.

Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.

Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients

This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.