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Reflux esophagitis involves inflammation of the esophagus due to acid exposure, and clinical trials seek to evaluate new approaches for managing this condition. Studies often explore treatment evaluations to reduce inflammation and protect the esopha...

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Found 88 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

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.

Age: 18Years - 65YearsAll Genders
1 location
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Actively Recruiting

Researchers are conducting an observational study to examine the endoscopic features of esophageal diseases in adults living at high altitude in Zaduo County. This study aims to compare these features with matched cases from Jilin Province to better understand how living above 4,200 meters affects upper gastrointestinal tract conditions such as reflux esophagitis. Participants who meet eligibility requirements will undergo sedated gastroscopy at Zaduo County Peoples Hospital between December 2025 and October 2026. The study will analyze endoscopic and pathological findings specific to this high-altitude population. These findings will include the presence of reflux esophagitis, chronic atrophic gastritis, the grade of the gastroesophageal flap valve, and Helicobacter pylori infection status. Participants will be assessed through painless gastroscopy with results collected within one to two weeks after the procedure. Researchers will track outcomes including the proportion of reflux esophagitis and other gastric conditions. The study involves no treatment intervention beyond standard diagnostic procedures, with participant involvement lasting from initial gastroscopy through post-procedure assessments. Safety and suitability are ensured by screening for contraindications and monitoring participant cooperation.

Age: 18Years +All Genders
1 location
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Actively Recruiting

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.

Age: 18Years - 75YearsAll Genders
1 location
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Actively Recruiting

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.

Age: 18Years - 75YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

This observational study analyzes data from a large prospective clinical registry to understand the characteristics and treatment outcomes of Chinese adults diagnosed with gastroesophageal reflux disease GERD. It aims to describe patient demographics, clinical features, psychological status, and treatment approaches while assessing improvements in GERD symptoms and psychological well-being after treatment. Researchers collected retrospective data on about 5,000 GERD patients treated at Beijing Friendship Hospital, including baseline information, diagnostic findings, psychological assessments before treatment, surgical complications, and long-term follow-up outcomes. The treatment types studied include pharmacological therapy and anti-reflux surgery, with data spanning up to 10 years post-treatment. Participants clinical records were reviewed to measure various outcomes such as symptom improvement, esophagitis severity, reflux indicators, and psychological health scores before and after treatment. The study also monitors surgical details, medication regimens, and postoperative complications. This comprehensive analysis provides insights to help guide personalized treatment decisions for GERD patients in China.

Age: 18Years - 90YearsAll Genders
1 location
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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

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.

Age: 15Years - 50YearsFEMALE
1 location
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Actively Recruiting

Healthy Volunteer

This trial evaluates the pharmacokinetics, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate in healthy adults aged 18 to 65 years. It is a Phase I, randomized, double-blind, placebo-controlled study designed to understand how the drug behaves in the body, its effects on heart electrical activity, and overall safety after dosing. Participants receive single oral doses of linaprazan glurate at varying levels 300 mg and 600 mg using formulation A, and 150 mg, 275 mg, and up to two additional dose levels using formulation C. A placebo group is included for comparison. The study uses a parallel-group design with quadruple masking to ensure unbiased results. During the study, participants undergo pharmacokinetic blood sampling and continuous ECG monitoring for up to 24 hours post-dose to measure drug levels and heart electrical activity changes. Researchers assess multiple ECG parameters, including QTcF, heart rate, PR and QRS intervals, and look for any abnormalities. Safety and tolerability are also monitored throughout. Total participation time per dose is about 24 hours.

Age: 18Years - 65YearsAll GendersPhase 1
1 location
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Actively Recruiting

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.

Age: 18Years +All Genders
1 location
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Actively Recruiting

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.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
1 location

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