Clinical Research Directory

Transoral Incisionless Fundoplication Database Repository (TIF)

Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.

Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty

The objective of this observational study is to compare parameters of diaphragmatic mechanics, respiratory muscle function, and thoracoabdominal kinematics among women with gastroesophageal reflux disease (GERD) and a history of abdominoplasty, women with a history of abdominoplasty alone, and women with GERD alone, seeking to understand whether the association between these conditions is linked to greater impairment of respiratory function and thoracoabdominal dynamics. The main question the study aims to answer is: Do women with GERD and a history of abdominoplasty exhibit greater impairment of diaphragmatic mechanics compared to those with a history of abdominoplasty alone and those with GERD alone? Researchers will compare three groups of participants: women with GERD and a history of abdominoplasty, women with a history of abdominoplasty alone, and women with GERD alone to determine whether the coexistence of GERD and abdominoplasty is associated with greater alterations in diaphragmatic mobility and thickness, respiratory muscle strength and endurance, thoracoabdominal kinematics, abdominal core and sternocleidomastoid muscle thickness, and body composition, as well as worse GERD-related symptoms and quality of life. Participants will undergo an initial clinical assessment, including medical history, anthropometric measurements, and body composition analysis via bioimpedance. They will also complete questionnaires regarding GERD symptoms, quality of life, and physical activity levels. Subsequently, assessments will be performed, including ultrasound of the diaphragm, abdominal muscles, and sternocleidomastoid muscle; spirometry; evaluation of thoracoabdominal kinematics; measurement of respiratory muscle strength via manovacuometry; and a respiratory muscle endurance test. When necessary for the diagnostic confirmation of GERD, 24-hour ambulatory esophageal impedance-pH monitoring will be performed. Upon completion of the assessments, the results obtained will be compared across the three groups to identify potential differences related to the association between GERD and abdominoplasty.

De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy

The goal of this clinical trial is to compare the effects of sleeve gastrectomy with and without omentopexy on gastroesophageal reflux disease (GERD) in patients with obesity. The main question it aims to answer is: Does the addition of omentopexy to sleeve gastrectomy reduce the incidence of postoperative GERD compared with sleeve gastrectomy alone, as measured by the proportion of participants with a postoperative GERD-Q score ≥8? Researchers will compare sleeve gastrectomy with omentopexy to sleeve gastrectomy without omentopexy to determine whether omentopexy reduces the incidence of postoperative GERD. Participants will: Undergo sleeve gastrectomy with or without omentopexy according to their randomized treatment assignment. Complete the GERD-Q questionnaire after surgery to assess gastroesophageal reflux symptoms. Attend postoperative follow-up visits for assessment of GERD and other clinical outcomes.

Mindfulness Intervention for Emotional Distress (MIED) in Patients With GERD

The goal of this multicenter randomized waitlist-controlled clinical trial is to evaluate whether an online Mindfulness-Based Intervention for Emotional Distress (MIED) can reduce emotional distress and reflux-related symptoms in adults with gastroesophageal reflux disease (GERD). GERD is a common chronic gastrointestinal condition that is frequently accompanied by anxiety, depressive symptoms, stress, and impaired quality of life. The main questions this study aims to answer are: Can online MIED reduce emotional distress in patients with GERD? Can online MIED reduce reflux-related symptoms and improve reflux-related quality of life? Are changes in psychological processes, such as distress tolerance, cognitive flexibility, experiential avoidance, emotional behaviors, and life engagement, associated with improvements in emotional distress and reflux symptoms? Researchers will compare participants receiving online MIED with participants in a waitlist control group receiving usual medical care and health management to determine whether online MIED leads to greater improvement over time. Participants will: complete screening and baseline assessments; be randomly assigned to either the online MIED intervention group or the waitlist control group; if assigned to the intervention group, complete an 8-week online MIED program with one session per week; continue necessary usual medical care during the study, while keeping medication use stable when possible; complete online questionnaires at baseline, during the intervention, after the intervention, and at 3, 6, 12, and 24 months after the intervention; report information on reflux symptoms, emotional distress, quality of life, sleep, stress, resilience, life satisfaction, healthcare use, intervention adherence, and adverse events.

Effect of Omeprazole on Gut Microbiota in Adults With Obesity and GERD

This randomized, open-label, parallel-group study will evaluate the effect of short-term omeprazole therapy on gut and oral microbiota in adults aged 50-65 years with obesity and symptomatic gastroesophageal reflux disease. Participants will be randomized 1:1 to receive omeprazole 20 mg once daily for 14 days plus standard non-pharmacological recommendations for gastroesophageal reflux disease, or standard non-pharmacological recommendations alone. Clinical and laboratory assessments will be performed at baseline and after 14 days. Stool and saliva samples will be collected to assess gut and oral microbiota, and blood samples will be collected for laboratory biomarkers.

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.

Stretta In Reflux Uncontrolled by IPP

The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.

Comprehensive Management Strategies for Gastroesophageal Reflux Disease: A Study of Multidimensional Interventions and Health Impacts

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder, with around 80% of patients experiencing nighttime symptoms. The prolonged nighttime reflux increases esophageal acid exposure, leading to complications like erosive esophagitis and extra-esophageal symptoms such as asthma and chronic cough. These symptoms disrupt sleep and affect daytime work and quality of life. Diet significantly influences GERD; high-fat foods, spicy foods, caffeine, carbonated beverages, and fermentable oligosaccharides disaccharides monosaccharides and polyols (FODMAPs) can worsen symptoms by lowering the pressure of the lower esophageal sphincter or delaying gastric emptying. Eating before bed or lying down immediately after meals can also aggravate symptoms. Treatment typically includes weight loss, bed elevation, smoking and alcohol cessation, avoiding meals before bedtime, and certain food restrictions. However, most dietary studies are observational, and there is limited evidence from randomized controlled trials. Proton pump inhibitors are standard treatments, but about 40% of patients do not achieve satisfactory symptom relief after treatment. Many of these patients suffer from disorders of gut-brain axis interaction (DGBI), characterized by visceral hypersensitivity and heightened esophageal vigilance. Additionally, these patients often have comorbid functional gastrointestinal disorders, increasing diagnostic complexity and leading to poor treatment outcomes. The interaction between visceral hypersensitivity, psychological distress, and central sensitization in GERD patients with functional gastrointestinal disorders remains unclear. This study aims to explore GERD symptoms and their influencing factors from multiple perspectives and propose non-pharmacological treatment strategies. The research focuses on nighttime reflux symptoms, dietary interventions, and the interaction between functional gastrointestinal disorders and GERD, providing empirical support to improve patients' symptoms and quality of life. The results of this study will help clarify the pathophysiological mechanisms related to GERD, esophageal DGBI, and functional gastrointestinal disorders. Additionally, the research findings will provide effective treatment strategies for patients with refractory reflux and DGBI in clinical settings.

Oral Fosamprenavir for GERD

The goal of this clinical trial is to learn if study drug Fosamprenavir administered orally improves symptoms for Proton Pump Inhibitor (PPI)-refractory Gastro Esophageal Reflux Disease (GERD). The main questions it aims to answer are: 1. Does fosamprenavir significantly improve heartburn severity over the 8-week treatment period 2. Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period 3. Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period Researchers will compare fosamprenavir to a placebo (a look-alike substance that contains no active drug) to see if fosamprenavir works to treat PPI-refractory GERD. Participants will: 1. Take fosamprenavir or placebo every day BID (twice a day) for 8 weeks 2. Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests 3. Keep a daily diary of their symptoms of persistent GERD

The Johns Hopkins Heartburn Center Registry

A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

Morphological Markers of Gastroesophageal Reflux Disease (GERD)

The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.

Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.

Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)

A majority of Fire Department of New York (FDNY) World Trade Center (WTC) exposed rescue and recovery workers developed gastroesophageal reflux disease (GERD), a risk factor for Barrett's Esophagus (BE) and subsequent esophageal cancer. There is diminished health-related quality of life and productivity associated with aerodigestive diseases such as GERD and BE. This proposal will leverage the longitudinally phenotyped WTC exposed cohort, validate biomarkers of WTC-aerodigestive disease, and develop novel, noninvasive disease phenotyping of premalignant diseases such as BE, and identify potential targeted therapeutics to improve care.

Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study

The study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. To demonstrate this hypothesis, the investigators will study the obese population suspected for GERD with 24 hours monitoring and High-Resolution Esophageal Manometry (HRM). DMS is calculated pre-operatively and, once GERD is confirmed, the patients are enrolled for randomization to SG or RYGBP. The suspicion of GERD is investigated with the GERDQ score and EGDS, that all obese patients have pre-operatory.

Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.

Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer

This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.

Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study

This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).

Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence

This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease

Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole

The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.

Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

The purpose of this randomized clinical trial is to learn if a mandibular advancement device (a type of oral appliance) can help reduce nighttime acid reflux in adults with obstructive sleep apnea. The study also aims to understand whether this device can improve sleep quality and quality of life. The main questions the study aims to answer are: * Does using a mandibular advancement device reduce the number and intensity of nighttime reflux episodes? * Does the device improve sleep and daily well-being in people with sleep apnea and reflux? Researchers will compare two types of oral appliances: * A mandibular advancement device, which moves the lower jaw forward during sleep * A lower jaw oral device without advancement, which also aims to help people with sleep apnea but does not reposition the jaw Participants will: Wear the assigned oral device every night for 6 months Visit the clinic for check-ups and adjustments Complete short questionnaires about reflux symptoms, sleep quality, swallowing, diet, and quality of life Have saliva pH measured and X-rays taken before and after using the device This study hopes to find out whether oral devices can be a good option for people who do not tolerate CPAP therapy.

Intestinal Microbiota After PPI Treatment

This clinical study aims to investigate the effects of short-term treatment with proton pump inhibitors (PPIs) on the gut microbiota of pediatric patients. PPIs are among the most frequently prescribed medications in children and adolescents for the management of acid-related disorders, such as gastroesophageal reflux disease (GERD). However, emerging evidence suggests that these medications may have unintended consequences on the delicate ecosystem of beneficial microorganisms residing in the human gastrointestinal tract. The intestinal microbiota plays a pivotal role in modulating immune responses, supporting nutrient metabolism, and maintaining the integrity of the gut barrier. Disruption of this microbial balance-known as dysbiosis-has been associated with several health conditions, including infections, allergies, obesity, and chronic inflammation. In adults, long-term PPI use has been linked to microbiota alterations, but data in the pediatric population remain limited and inconclusive. To address this gap, our prospective longitudinal study will recruit pediatric patients prescribed PPI therapy for clinical indications. Stool samples will be collected at four time points: prior to PPI administration, during treatment, and at two follow-up stages post-cessation. Using 16S rRNA gene sequencing, we will profile changes in microbial diversity and abundance over time. The results will offer insight into whether short-term PPI exposure in children leads to significant, lasting changes in gut microbiota composition or diversity. Such information may ultimately inform prescribing practices, support personalized therapeutic strategies, and help mitigate potential risks associated with microbiota disruption during childhood-a critical period for microbial and immune system development.

A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice

A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD. Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.

Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients

A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication procedure prior to Laparoscopic Sleeve Gastrectomy surgery to Laparoscopic Roux-en-Y Gastric Bypass in bariatric patients with Gastroesophageal Reflux Disease signs and symptoms. The aim of this study is to examine the effect of TF prior to sleeve gastrectomy as compared to Roux-en-Y Gastric Bypass on reflux symptoms in bariatric patients. Additional Follow up data until 10 years will be collected to evaluate for sequelae of GERD.

Evaluation of Upper Esophageal Sphincter Motor Activity in Patients with Extra Esophageal Reflux Symptoms

To evaluate the presence of motor changes of the upper esophageal sphincter detectable by high-resolution manometry in patients with oropharyngeal symptoms referable to extra-esophageal reflux manifestations.