466 Clinical Trials for Various Conditions
The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily \[QD\]) in children ≥ 6 to \< 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
More than 40% of patients with gastroesophageal reflux disease (GERD) experience uncontrolled, chronic symptoms. This proposal aims to improve symptom control for patients with GERD, by developing a mobile health (mHealth) Question Prompt List (QPL) intervention that helps patient ask questions with his/her physician about GERD. The first aim is to gather feedback about daily challenges of living with GERD. The second aim is to gather feedback on the prototype app. The third (primary) aim of this project is to develop the mHealth application and measure differences in patient activation when used compared to standard of care.
The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive reflux disease (NERD) or healed erosive esophagitis (EE).
After defining the manometric characteristics of UES incompetence associated with documented pharyngeal reflux, we will determine the reproducibility of manometric criteria for UES incompetence in prevention of pharyngeal reflux. We hypothesize that these criteria are comprised of either a single or constellation of manometric abnormalities. After determining the ability of externally applied cricoid cartilage pressure in preventing pharyngeal reflux, we further hypothesize that this approach will eliminate or reduce esophago-pharyngeal reflux by enhancing the UES pressure barrier. We anticipate there will be a close spatial correlation between the site of applied pressure and area of increased pressure within UES high pressure zone. Lastly, we will determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow, testing the hypothesis that these functions will not be impaired.
The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily \[QD\]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
GERD affects roughly 20% of the U.S. population and the direct and indirect costs of GERD are substantial, totaling close to 50 billion dollars per year. Evidence supports that a large proportion of this cost and poor clinical outcomes in GERD are related to poor healthcare decisions by both the physician and the patient. The problem of inappropriate GERD management stems from three main issues. First, the disease is heterogeneous and requires treatment informed by a precision model. Second, the current paradigm largely ignores the important brain-gut interactions that drive symptoms and healthcare utilization. Third, there is a paucity of well-performed comparative effectiveness trials focused on assessing treatments beyond acid suppression. We will use physiomarkers defined during the previous funding cycle to phenotype the patients and use cognitive behavioral interventions to modulate hypervigilance to test the Psycho-Physiologic Model of GERD. Cognitive Behavioral Therapy (CBT) is able to improve hypervigilance and symptom specific autonomic arousal and thus, we will test our theory that CBT can improve outcomes in GERD by targeting these two important psychologic stressors. We will also continue our focus on the interplay of psychology and physiology by determining whether increased mucosal permeability is associated with reflux perception and whether this is modified by hypervigilance and autonomic disruption.
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.
Gastroesophageal reflux disease related symptoms are reported by 10-20% of the adult population and of those 50-75% report symptoms during sleep time. The prevalence of nocturnal GERD (nGERD) is estimated to be about 25% in general population. nGERD causes sleep fragmentation, difficulty falling asleep, daytime sleepiness, reduced work productivity and decreased quality of life. Additionally, nighttime gastroesophageal reflux has been associated with increased risk of GERD-related complications such as severe erosive esophagitis, peptic stricture, esophageal ulcer, Barrett's esophagus, and esophageal adenocarcinoma. Furthermore, nocturnal gastroesophageal reflux has been noted to be associated with atypical and extra-esophageal manifestations as well as sleep disturbances. Overall, patients with nocturnal gastroesophageal reflux are more likely to develop a more severe form of GERD. The mainstay of treatment of nighttime gastroesophageal reflux is a proton pump inhibitor (PPI). However, nighttime heartburn is the most common breakthrough symptom in patients with GERD, who failed PPI treatment. Other important therapies for nighttime GERD include, lifestyle modifications, such as elevating the head of the bed, avoiding eating at least three hours before bedtime, maintaining appropriate sleep hygiene and avoiding the right decubitus position. Elevating the upper torso by raising the head of the bed and avoiding the right-lateral decubitus position have been shown to improve nocturnal symptoms. Several studies have shown that sleeping in the left decubitus position decrease esophageal acid exposure by reducing 13-76% of the reflux episodes. Studies have shown that the right decubitus position increases the rate of transient lower esophageal sphincter relaxations (TLESRs) accompanied by acid reflux, as compared with the left recumbent position. Moreover, maintaining the left lateral recumbent position, reduced by 87% esophageal acid exposure and nocturnal symptoms. LEFT is a novel electronic wearable device that was developed as a sleep position therapy for patients who suffer from nighttime gastroesophageal reflux symptoms. It is simple, noninvasive and low-cost technology which has been developed by Side Sleep Technologies B.V. Singel, Amesterdam, The Netherland. This technology is designed to train patients to sleep on their left side by a gentle vibration signal once it detects that they are sleeping on their back or right side. Thus, this technique may reduce gastroesophageal reflux and thus provides relief of heartburn and regurgitation during sleep time. The purpose of this study is to determine the usefulness of positional therapy, using the LEFT device, as a nonmedical tool to control GERD-related nocturnal symptoms.
This is a remote study. No office visits required. The purpose and efficacy endpoint of this study is to assess whether GERD patients tolerate ISOT-101. In addition, usage of the ReQuest validated questionnaire to measure GERD symptoms will be explored as well as usage of the validated SF-36 quality of life (QoL) questionnaire. Each subject serves as his/her own control. Relative tolerability in subjects both on and off proton pump inhibitors (PPIs) will be compared. Subjects naive to PPIs, currently taking PPIs and historically on PPIs will be evaluated with ReQuest and QoL scores. In addition, survey measurements will be taken on a subset of 10 subjects that are non-responders to PPIs. These will not be included in the statistical analysis with the above groups. A tertiary endpoint of this study is to assess any relevant adverse events that occur.
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
The goal of this clinical trial is to learn if dietary changes can help improve gastroesophageal reflux disease (GERD) symptoms. The main question\[s\] it aims to answer whether the Gracie Diet is an option to treat GERD symptoms in individuals wish to discontinue standard doses of PPI and / or H2 receptor antagonists. Participants will be taken off PPI and be placed on the Gracie Diet for 8 weeks. Information about the participants reflux symptoms and GERD health related quality of life will be collected to assess the effect of the diet.
This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
This study will use a 22 gene pharmacogenomics panel on 30 children with persistent Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
Primary Objective: Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. Secondary Objectives: To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak. Quality of life at study entry and end of study. Compare two medications under study within each group as a subgroup analysis.
The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers. Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.
This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family. In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.
The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.
The purpose of this study is to find out if people who have non-erosive reflux disease (NERD) have changes the investigators can see with a microscope (called confocal endomicroscopy) that is used during endoscopy (a camera scope evaluation of the inside of your stomach and swallowing tube). Traditionally the investigators have used trials of acid blocking medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the esophagus) to determine if the investigators think acid is causing troublesome symptoms. The medical community believes that these symptoms are due to increased spaces between the cells that make up the swallowing tube. The investigators can directly see those spaces with a new microscope that the investigators can pass through the camera scope. Participants will be assigned to take one of two medications omeprazole and sucralfate (both approved medications for stomach symptoms) to treat their symptoms and record how well the treatment works. The investigators then will look to see if the microscope can predict which medication will work best for patients in the future. The investigators also plan to measure the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube and stomach as this is standard for patients with your symptoms. The investigators will compare the results of those studies to the microscope findings.
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.
The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis. If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.
The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).
The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on \~100 patients who have GERD to assess effectiveness.
By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of gastric contents. The investigators hypothesized that the loss of weight will decrease this gradient and as a result decrease the severity and frequency of GERD symptoms. GERD negatively affects health related quality of life. Since loss of weight may decrease gastroesophageal reflux, the investigators hypothesized that it obesity contributes to poor quality of life in GERD subjects and losing weight should also favorably impact and improve quality of life in GERD patients.