Reflux Esophagitis

Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease (GERD) in patients who have undergone laparoscopic gastric sleeve (LGS) surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Researchers are evaluating PepZinGI45, a zinc-L-carnosine dietary supplement, to see if it reduces food-triggered heartburn compared with placebo. This randomized, double-blind, placebo-controlled crossover study includes adults with self-reported food-triggered heartburn occurring at least once per week. The study also examines sleep outcomes related to heartburn, using various questionnaires and wearable device metrics. Participants take PepZinGI and a placebo each for one week, separated by a two-week washout period, totaling 29 days. During each treatment week, participants consume a hurdle meal designed to trigger heartburn. The study is fully remote with no in-person visits, and all activities are completed through the Alethios platform. Throughout the study, participants complete electronic surveys on heartburn severity and frequency and sleep quality at baseline, day 8, and day 29. Wearable devices track sleep duration, quality, resting heart rate, heart rate variability, and restlessness continuously from baseline through day 29. Participant satisfaction is also assessed with questionnaires after each treatment phase. Rescue medication use and timing of symptom relief are recorded, ensuring comprehensive monitoring of heartburn and related sleep outcomes.

This observational study aims to evaluate the effectiveness of Danning Tablets in relieving dyspepsia symptoms in patients who experience digestive issues such as upper abdominal pain, bloating, loss of appetite, acid reflux, or constipation. It seeks to understand how factors like symptom severity, patient demographics, dosage, and treatment duration influence the tablets' impact. The study is sponsored by Shanghai Hutchison Pharmaceuticals Limited and focuses on patients already using Danning Tablets in their regular care. Participants in this study are adults aged 18 to 75 who are currently taking Danning Tablets for indigestion symptoms as part of their regular treatment. The study involves collecting questionnaire responses at two and four weeks after starting their treatment to assess changes in symptoms and quality of life. There is no control group since this is an observational study of patients already taking the medication. Throughout the study, participants will complete assessments measuring the rate of symptom improvement, including dyspepsia symptom relief, gastrointestinal symptom rating scales, abdominal pain ratings, and quality of life using the EQ-5D-5L questionnaire. Adverse events are also monitored during the two- and four-week periods. The main outcome is the responder rate for dyspepsia symptoms at four weeks after enrollment, with all participation lasting up to four weeks.

Researchers are evaluating the healing rates of reflux esophagitis classified as LA grade B or higher. This study compares three treatments: Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg, taken once daily for 8 weeks. The purpose is to assess which treatment helps heal the esophagus and improves reflux symptoms, as measured by the GERD-Q score, while also monitoring for side effects. Participants will be randomly assigned to one of three groups to receive either Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks. The study is open-label, meaning participants and doctors know the treatment given, but those assessing the healing results are blinded to reduce bias. Treatments focus on acid reduction to promote healing. During the study, participants undergo an upper gastrointestinal endoscopy at the start to confirm esophagitis severity and again after 8 weeks to check healing progress. GERD symptoms are recorded at the beginning, at 4 weeks, and at 8 weeks. Researchers also track medication adherence and any adverse events. The main outcome is the healing of esophagitis at 8 weeks, alongside symptom improvement and safety monitoring throughout the treatment period.

Researchers are evaluating how often small intestinal bacterial overgrowth (SIBO) happens after people with gastroesophageal reflux disease (GERD) take proton pump inhibitors (PPIs). The study focuses on patients who have symptoms like heartburn and regurgitation and aims to better understand the relationship between PPI use and SIBO occurrence. This is an interventional study conducted by the Mayo Clinic. Participants with GERD symptoms who have been treated with a short course of PPIs will undergo breath testing to check for SIBO. During the breath test, participants drink a small carbohydrate solution and provide breath samples every 15 minutes for one hour, then every 30 minutes for the next two hours. This testing occurs approximately 8 weeks after PPI therapy to measure SIBO incidence and symptoms. Throughout the study, researchers will assess the presence of SIBO and related symptoms both before and after PPI treatment. Breath testing schedules and symptom evaluations will help determine changes associated with PPI use. The main outcome is the rate of SIBO after PPI therapy, with additional measures of symptoms and SIBO status at baseline. The study does not specify a maximum age and will enroll adults 18 years and older. Participants will be monitored until about 8 weeks after treatment.

Researchers are evaluating the safety of vonoprazan exposure during pregnancy by comparing outcomes for pregnant women who take vonoprazan with those who do not but may use other treatments for similar conditions. The study focuses on maternal, fetal, and infant health, particularly monitoring for congenital malformations and various pregnancy outcomes related to erosive esophagitis, heartburn, symptomatic non-erosive gastroesophageal reflux disease, and Helicobacter pylori infection. The study includes two groups: pregnant women exposed to vonoprazan and those not exposed but possibly treated with other medications for related conditions. Vonoprazan is given as an oral tablet. Participants are observed from conception through pregnancy outcome, and infants are followed for up to 12 months after birth to assess health and development. Participants will provide consent and authorize their healthcare providers to share relevant data. Researchers will track major and minor congenital malformations, spontaneous abortion, stillbirth, elective termination, preterm birth, small gestational age at delivery, postnatal growth deficiencies, and developmental delays. Follow-up includes monitoring pregnancy outcomes and infant development for up to one year after birth, ensuring comprehensive safety evaluation over time.

Achalasia is a rare condition caused by the loss of nerve cells in the lower esophagus, leading to swallowing difficulties. Researchers are studying the occurrence of gastroesophageal reflux disease (GERD) and esophagitis in patients who have undergone peroral endoscopic myotomy (POEM), a minimally invasive treatment designed to address achalasia. This observational study aims to understand how often reflux and silent GERD appear after POEM and to identify factors linked to these outcomes. Participants in this study are achalasia patients who have had the POEM procedure. They will undergo various assessments before and after treatment, including scoring of symptoms, questionnaires about reflux symptoms, high-resolution esophageal pressure tests, endoscopic examinations, and pH monitoring to measure acid exposure. No new treatments are given; the study focuses on monitoring and evaluating the effects after POEM. During the study, participants will have follow-up evaluations over a period of up to 36 months to track the presence of reflux and esophagitis. Researchers will collect data on patient symptoms, test results, and procedural details to analyze risk factors associated with post-POEM GERD. The main outcome measured is the prevalence of gastroesophageal reflux after the procedure. The study is sponsored by the Maria Sklodowska-Curie National Research Institute of Oncology and does not involve healthy volunteers.

Researchers are evaluating a new minimally invasive endoscopic therapy called antireflux mucosal ablation (ARAT) using hybrid argon plasma coagulation for adults with chronic gastroesophageal reflux disease (GERD). This condition affects many adults who continue to have symptoms despite medical therapy. The study aims to compare the safety and effectiveness of ARAT to a sham procedure in patients with typical GERD symptoms at least twice a week for six months and objective evidence of reflux. Participants will be randomly assigned to receive either the ARAT intervention or a sham procedure. The ARAT treatment involves cleaning and marking the cardia area of the stomach followed by injections to raise the mucosa and targeted ablation using pulsed argon plasma coagulation. The sham group will undergo a similar endoscopic examination without ablation or injections. Patients continue their proton pump inhibitor (PPI) medication daily for four weeks after the procedure. Follow-up visits are scheduled at 3, 6, and 12 months to assess outcomes. During the study, participants will have upper endoscopies and ambulatory pH monitoring at 3 and 12 months, along with completing validated GERD symptom questionnaires. Phone calls for adverse event monitoring occur shortly after the procedure and at 1 month. Researchers will measure changes in GERD symptom scores, esophageal acid exposure, and PPI use over one year. Patients with any complications such as dysphagia will receive appropriate evaluation and treatment. The total study duration from randomization to completion is one year, with an overall project timeline of about 24 months including screening and data analysis.

Researchers are evaluating the relative benefits, safety, and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) compared to daily Proton Pump Inhibitors (PPIs) in patients with Gastroesophageal Reflux Disease (GERD). This trial aims to better understand how ARMV, a minimally invasive procedure, compares to standard PPI treatment in managing GERD symptoms and improving patients' quality of life. The ARMV procedure is performed under general anesthesia, using an endoscope to release and reconstruct a segment of mucosa at the esophagogastric junction to form a mucosal flap. This flap is secured with metal clips to prevent flattening and promote reflux prevention. Patients continue PPI therapy for one month after ARMV to aid healing before stopping the medication. The comparison group continues PPI treatment with dosage adjustments based on symptom control. PPI use is carefully recorded in medication diaries. Participants will undergo endoscopic examination and various follow-up assessments including symptom questionnaires, esophageal pH monitoring, and endoscopic evaluations over up to three years. Key outcomes include GERD-related quality of life, reflux scores, esophagitis presence, mucosal flap appearance, PPI usage, and adverse events. Researchers will closely monitor participants' symptoms, medication use, and safety throughout the study period, which lasts until December 2028.

Researchers are studying Barrett's Esophagus (BE), a condition caused by chronic acid reflux that increases the risk of esophageal cancer. This study evaluates advanced endoscopic techniques such as high resolution endoscopy (HRE), narrow band imaging (NBI), and chromoendoscopy to improve the detection of early neoplastic changes in BE. The study also aims to develop a video atlas and classification system to help recognize these changes and assess their accuracy and agreement among observers. The study involves performing standard endoscopy followed by HRE, NBI, and chromoendoscopy on patients with BE. Abnormal lesions identified during endoscopy will be removed using endoscopic mucosal resection (EMR) or mucosal ablation. Digital video recordings of these procedures will be collected for analysis. This is part of a multicenter study with patients recruited from various locations. Patients will also complete questionnaires about their reflux symptoms and medication use. Participants will undergo physical exams, complete questionnaires, and have their endoscopic procedures recorded and analyzed. Researchers will track the detection rates of early esophageal cancer or precancerous lesions and review pathologic and clinical outcomes including any complications from EMR or ablation. The study will also assess agreement between observers using the video atlas and classification system. Participation may last several years, with ongoing monitoring of outcomes from 2007 through 2016.