[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"reflux-esophagitis-re\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:reflux-esophagitis-re":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100639694","pilot-study-of-salivary-bile-acids-and-pepsin-as-predictive-biomarkers-of-reflux-disease-after-sleeve-gastrectomy-100639694",false,"NCT07607067","Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease After Sleeve Gastrectomy","Prospective Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease and Esophageal Injury After Sleeve Gastrectomy","ABSORB","Inclusion Criteria:\n\n* Adults aged 18 years or older undergoing sleeve gastrectomy at a participating center.\n* Indication for obesity treatment with sleeve gastrectomy according to the 2022 ASMBS-IFSO consensus criteria, with a maximum body mass index (BMI) of 50 kg\u002Fm².\n* Approved for sleeve gastrectomy by the obesity multidisciplinary committee.\n* Ability and willingness to provide informed consent for biological sample collection and analysis.\n* Ability to understand and comply with scheduled follow-up visits.\n\nExclusion Criteria:\n\n* According to Lyon 2.0 criteria, participants with previous evidence of conclusive reflux disease, including Los Angeles grade B, C, or D esophagitis, peptic stricture, or Barrett's esophagus diagnosed before surgery.\n* Bariatric procedures other than sleeve gastrectomy, including Roux-en-Y gastric bypass or revisional bariatric surgery.\n* History of other preexisting esophageal diseases.\n* Previous esophageal surgery.\n* Active cholestatic hepatobiliary disease or treatment with bile acid sequestrants, ursodeoxycholic acid, or medications that significantly alter bile acid metabolism at the time of saliva sampling or within one month before sample collection.\n* Acute infection or systemic antibiotic treatment within four weeks before saliva sample collection.\n* Pregnancy or breastfeeding.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},60,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of this observational study is to learn whether bile acids and pepsin in saliva can help identify adults at higher risk of developing reflux-related esophageal disease after sleeve gastrectomy, including Los Angeles grade B-D erosive esophagitis and Barrett's esophagus. The study will include adults undergoing sleeve gastrectomy as part of their regular clinical care. Participants will be evaluated before and after surgery and will serve as their own comparison group over time.\n\nThe main questions it aims to answer are:\n\nAre saliva bile acids and pepsin linked to Los Angeles grade B-D erosive esophagitis or Barrett's esophagus after sleeve gastrectomy? How do saliva bile acids and pepsin change before and after sleeve gastrectomy? Can saliva bile acids and pepsin become useful biomarkers for detecting reflux-related esophageal disease after sleeve gastrectomy? Are saliva biomarker levels linked to reflux symptoms and endoscopy results after surgery?\n\nResearchers will compare saliva biomarker levels before and after surgery and between participants with and without reflux-related esophageal disease.\n\nParticipants will:\n\nProvide saliva samples before surgery and at 12 and 36 months after surgery Provide fasting and post-meal saliva samples Undergo routine postoperative clinical follow-up and upper gastrointestinal endoscopy Complete reflux symptom questionnaires during follow-up\n\nThe study will also explore whether saliva biomarkers could help select participants for follow-up endoscopy after sleeve gastrectomy.",[28,29,30,31,32],"Reflux Disease, Gastro-Esophageal","Sleeve Gastrectomy","Saliva Collection","Reflux Esophagitis (RE)","Barrett Esophagus",[34,35,36,37,32],"sleeve gastrectomy","bile acid reflux","salivary biomarkers","erosive esophagitis","NOT_YET_RECRUITING","2026-05-19",{"date":41,"type":42},"2026-05-26","ACTUAL",{"date":44,"type":23},"2026-12",{"date":46,"type":23},"2029-12",{"name":48,"class":49},"Hospital de Mataró","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100593720","phase-3-a-clinical-trial-of-anaprazole-for-treating-reflux-esophagitis-100593720","NCT07010107","A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.","Efficacy and Safety of Anaprazole in the Treatment of Reflux Esophagitis: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Positive-Controlled Phase III Clinical Trial.","Inclusion Criteria:\n\n1. The patients provided voluntary signed informed consent forms.\n2. Aged ≥18 years and ≤75 years old.\n3. Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.\n\nExclusion Criteria:\n\n1. Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory, hepatic, renal, or other systems.\n2. Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.\n3. Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.\n4. Patients confirmed to have active peptic ulcers or active upper\u002Flower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).\n5. Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional disorders.\n6. Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.\n7. Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.\n8. Patients who tested positive for HIV, HBsAg, and\u002For HCV antibodies during screening.\n9. Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus.\n10. Patients with abnormal liver function: AST and\u002For ALT levels ≥2.0×ULN, and\u002For total bilirubin (TBIL) levels ≥1.5×ULN.\n11. Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN.\n12. Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women).\n13. Patients with poorly controlled diabetes or hypertension.\n14. Patients who were unable to undergo esophagogastroduodenoscopy (EGD).\n15. Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole.\n16. Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization.\n17. Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization.\n18. Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period.\n19. Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study.\n20. Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion.\n21. Patients who had participated in other drug clinical trials within 3 months prior to randomization.\n22. Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.","75 Years",{"count":59,"type":23},500,"INTERVENTIONAL",[62],"PHASE3","This Phase III clinical trial is designed to assess the efficacy and safety of Anaprazole 60 mg once daily (QD) administered over a period of up to 8 weeks, compared with Rabeprazole 20 mg QD, in patients with reflux esophagitis.",[31],[66,67,68],"Anaprazole","Rabeprazole","Reflux Esophagitis","RECRUITING","2025-09-23",{"date":72,"type":42},"2025-09-29",{"date":74,"type":42},"2025-07-30",{"date":76,"type":23},"2026-08",{"name":78,"class":79},"Xuanzhu Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":88,"targetDuration":4,"studyType":60,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":80},"100581451","phase-3-a-phase-iii-clinical-trial-for-efficacy-and-safety-evaluation-of-jp-1366-tablets-on-reflux-esophagitis-100581451","NCT06850480","A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis","A Multicenter, Randomized, Double-blind, Double-simulated, Positive Parallel-control Phase III Clinical Trails of JP-1366（Zastaprazan Citrate） Tablets and Nexium® on Reflux Esophagitis","Inclusion Criteria:\n\n1. Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;\n2. Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.\n3. Those who have experienced heartburn and reflux symptoms (with medical records) within 7 days before screening or who have been diagnosed with reflux esophagitis by endoscopic examination within 7 days before screening;\n4. Screening period for upper gastrointestinal endoscopy, diagnosed with grade A-D reflux esophagitis in Los Angeles (those who have received endoscopic examination results from our center, have been judged by researchers to meet the diagnostic criteria, and have not been examined within 14 days before randomization, do not need to repeat this examination).\n5. LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage \\> 4%;\n6. Women of childbearing age or significant other male subjects of childbearing age are willing to use effective contraceptive measures throughout the study period, such as oral, implanted, or injected contraceptive hormones, or use mechanical products such as intrauterine devices or barrier methods (uterine caps, , spermicides), or practice abstinence or self\u002Fsignificant other sterilization (such as vasectomy, hysterectomy, bilateral salpinectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n1. Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;\n2. Those who cannot accept upper gastrointestinal endoscopy;\n3. Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;\n4. History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;\n5. Screening for patients with active peptic ulcers and active upper\u002Flower gastrointestinal bleeding within the first 3 months; or patients with a history of active peptic ulcers and active upper\u002Flower gastrointestinal bleeding more than 3 months after screening, and those who did not recover after endoscopic examination of the upper gastrointestinal tract during the screening period;\n6. Patients with concomitant diseases that may affect esophageal motility (such as scleroderma, viral infection or fungal infection, etc.), or those with a history of esophageal radiotherapy or cryotherapy;\n7. Have undergone surgery to reduce gastric acid secretion, or any surgery that affects the structure or function of the esophagus, stomach, or duodenum (except for benign tumor resection, benign polyp endoscopic resection, simple suture surgery such as gastric perforation);\n8. Subjects with warning symptoms of upper gastrointestinal malignancies or gastrointestinal malignancies (such as swallowing pain, severe dysphagia, bleeding, weight loss, anemia, hemoptysis or hematochezia) (except for those with negative endoscopic malignancies);\n9. People with a history of the following clinically significant diseases:\n\nThose with a history of hemorrhagic stroke or any of the following intracranial diseases (bleeding, tumors, arteriovenous malformations (AVMs), or aneurysms); There are recurrent upper gastrointestinal or gastrointestinal ulcers\u002Fbleeding, and researchers believe that there is an increased risk of bleeding or clinical bleeding has occurred within the past 6 months before screening.\n\nThose who have had acute clinical hepatitis or a history of major liver disease (active phase of chronic hepatitis, cirrhosis, or chronic liver dysfunction) within the past year before screening.\n\nScreening for those who have had myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within the past 6 months; those who have undergone coronary artery revascularization within 6 months; transient ischemic attack or ischemic stroke.\n\nPatients with a history of chronic congestive heart failure and NYHA IV heart function.\n\nThere are severe arrhythmias that require treatment with Class Ia or III antiarrhythmic drugs; arrhythmias with diseased sinus syndrome, Class II or III atrioventricular block, and pacemakers have not yet been implanted.\n\nPeople with a history of prolonged QTc interval or screening period with QTc interval ≥ 480ms (according to Fridericia correction formula, where QTc = QT\u002FRR \\^ 0.33).\n\nSubjects with any history of active malignant tumors within the first 5 years of screening (excluding cured basal cell carcinoma, papillary thyroid carcinoma, and radical resection of carcinoma in situ such as intraductal carcinoma of the and cervical carcinoma in situ).\n\nSubjects who need to continue receiving non-steroidal anti-inflammatory drugs (such as aspirin), systemic corticosteroids, or antithrombotic drugs during the trial period (excluding those who use prophylactic low-dose aspirin (≤ 100mg\u002Fday)).\n\n12\\. Subjects who have taken gastric acid inhibitors (e.g. P-CAB, PPI) within 2 weeks before the first dose; or subjects who have taken H2 receptor blockers within 1 week before the first dose; 13. Subjects who were using retroviral antiviral drugs such as azanavir and nefinavir at the time of screening; 14. Those who meet any of the following requirements during the screening: Serum creatinine \\> 1.5 × ULN; history of chronic kidney disease, estimated glomerular filtration rate (eGFR) \\\u003C 30ml\u002Fmin\u002F1.73m2.\n\nTotal bilirubin \\> 1.5 × ULN, alanine aminotransferase (AST)\u002Faspartate aminotransferase (ALT) \\> 3 × ULN.\n\n15\\. Have participated in any systemic therapeutic drug clinical trial (defined as administered) within the first 3 months of screening or within 5 half-lives of the test drug (whichever is longer); 16. Pregnant or lactating women; 17. The investigator determines that the subjects are not suitable to participate in this experiment.",{"count":89,"type":23},356,[62],"To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.",[31],"2025-02-21",{"date":95,"type":42},"2025-02-27",{"date":97,"type":42},"2024-12-05",{"date":99,"type":23},"2025-04-30",{"name":101,"class":79},"Livzon Pharmaceutical Group Inc."]