[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-gastritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-gastritis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,66,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100537028","safety-and-efficacy-study-of-betaine-hydrochloride-in-treating-hypergastrinemia-in-patients-with-autoimmune-gastritis-100537028",false,"NCT06272500","Safety and Efficacy Study of Betaine Hydrochloride in Treating Hypergastrinemia in Patients With Autoimmune Gastritis","Safety and Efficacy Study of Betaine Hydrochloride in Treating Hypergastrinemia in Patients With Autoimmune Gastritis.","Inclusion Criteria:\n\n\\- 1) Patients diagnosed with autoimmune atrophic gastritis at the First Affiliated Hospital of Zhengzhou University, using the diagnostic criteria from the \"Guidelines for the Diagnosis and Treatment of Chronic Gastritis in China (2022, Shanghai)\" for the diagnosis of atrophic gastritis, combined with serum gastrin, PCA, or IFA for the diagnosis of autoimmune atrophic gastritis.\n\n2\\) Patients who have signed the informed consent form for the clinical trial.\n\nExclusion Criteria:\n\n* 1\\) Patients with Betaine hydrochloride allergies. 2) Patients with gastric ulcers, gastroesophageal reflux disease, or cholelithiasis, as the administration of acid agents may worsen the condition or cause discomfort.\n\n  3\\) Patients with gastrinomas or other conditions that can cause elevated gastrin levels, apart from autoimmune atrophic gastritis.\n\n  4\\) Patients who are unable to provide informed consent or sign the informed consent form.","ALL",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"NA","Autoimmune atrophic gastritis (AAG) is an organ-specific autoimmune disease that primarily affects the gastric body and fundus while sparing the antrum. Its characteristics include destruction of gastric wall cells, loss of intrinsic factors, and atrophy of the gastric mucosa. Endoscopic examination reveals features of reverse atrophy, with significant atrophy in the gastric body and fundus, appearing as a mosaic of red and white patches. Currently, AAG is believed to result from a pathological CD4+ T-cell-mediated autoimmune response against the gastric H+\u002FK+-ATPase. CD4+ T lymphocytes target the parietal cells' H+\u002FK+-ATPase, stimulating plasma cells to secrete autoantibodies, including parietal cell antibodies (PCA) and intrinsic factor antibodies (IFA). The former plays a key role in parietal cell destruction and glandular atrophy. AAG is considered a premalignant condition, with the potential development of gastric dysplasia, cancer, and type 1 gastric neuroendocrine tumours (type 1 g-NET).\n\nGastric neuroendocrine tumors (g-NETs), also known as gastric carcinoids, account for approximately 23% of gastrointestinal and pancreatic neuroendocrine tumors. Clinically, g-NETs are mainly classified into three types. Type III is typically sporadic tumors associated with normal gastrin levels and poor prognosis. Although type 1 g-NETs caused by AAG are usually well-differentiated, studies have reported that 8%-23% of type 1 g-NETs extending into the deep submucosal layer may metastasize to regional lymph nodes or even to the liver. Furthermore, 3% of patients may develop neuroendocrine carcinoma, highlighting the need for appropriate attention.\n\nDue to the destruction of gastric glands (including parietal and chief cells) in AAG patients, there is a deficiency in intrinsic factor, gastric acid, and a decrease in pepsinogen I (PG-I) levels. Insufficient gastric acid secretion leads to a compensatory increase in gastrin secretion by G cells in the gastric antrum, which acts on receptors present in enterochromaffin-like cells (ECL) in the gastric body and fundus, promoting ECL cell proliferation. Prolonged stimulation by hypergastrinemia can result in the development of ECL cell tumors, namely type 1 g-NETs. Considering the close association between type 1 g-NETs and AAG, primarily related to hypergastrinemia resulting from reduced gastric acid secretion, it is hypothesized that supplementation with gastric acid could provide negative feedback regulation of gastrin, reducing the risk of type 1 g-NET development in AAG patients. This study aims to investigate the impact of Betaine hydrochloride(BHCL) on gastrin levels in AAG patients, thus exploring a simple and cost-effective method to reduce the risk of type 1 g-NETs in AAG patients.",[25],"Autoimmune Gastritis","RECRUITING","2026-06-12",{"date":29,"type":30},"2026-06-16","ACTUAL",{"date":32,"type":30},"2024-01-01",{"date":34,"type":19},"2026-06-30",{"name":36,"class":37},"Jianning Yao","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":38},"100588845","assessing-the-prevalence-and-epidemiological-characteristics-of-small-intestinal-bacterial-overgrowth-sibo-in-patients-with-autoimmune-gastritisaig-through-hydrogen-and-methane-breath-testinghmbt-100588845","NCT06946706","Assessing the Prevalence and Epidemiological Characteristics of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Autoimmune Gastritis(AIG) Through Hydrogen and Methane Breath Testing(HMBT).","Assessing the Prevalence and Epidemiological Characteristics of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Autoimmune Gastritis (AIG) Through Hydrogen and Methane Breath Testing (HMBT).","HMBT、SIBO、AIG","Inclusion Criteria:\n\n* Inclusion criteria for the AIG group:\n\n  1. Age range: 18-65 years old, without gender limitation;\n  2. Patients diagnosed with AIG: Previous gastroscopy (or) histological findings consistent with AIG, and serological tests support the diagnosis of AIG;\n  3. Previous colonoscopy or intestinal CT have ruled out inflammatory bowel disease, malignant tumors, history of pseudo and mechanical bowel obstruction, and there is currently no evidence to support these diseases;\n  4. At least 2 weeks without taking PPI\u002FP-CAB;\n  5. Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring;\n  6. Capable of completing the signing of informed consent forms as required.\n\nInclusion criteria for the acid suppression group:\n\n1. Age: 18-65 years old, without gender limitation;\n2. Patients who are non-AIG and need long-term acid inhibitor (PPI more than 8 weeks or P-CAB more than 4 weeks) due to gastroesophageal reflux and other reasons;\n3. Patients with a 1-year history of gastroscopy, with no degree of microscopic atrophy, or with mild gastric mucosal atrophy (C-I and C-II according to the Kimura-Takemoto classification);\n4. Previous colonoscopy or intestinal CT have ruled out inflammatory bowel disease, malignant tumors, history of pseudo and mechanical bowel obstruction, and there is currently no evidence to support these diseases;\n5. Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring;\n6. Capable of completing the signing of informed consent forms as required.\n\nInclusion criteria for the control group:\n\n1. Age: 18-65 years old, without gender limitation;\n2. Patients with a 1-year history of gastroscopy, with no degree of microscopic atrophy, or with mild gastric mucosal atrophy (C-I and C-II according to the Kimura-Takemoto classification);\n\n4\\) Previous colonoscopy or intestinal CT have ruled out inflammatory bowel disease, malignant tumors, history of pseudo and mechanical bowel obstruction, and there is currently no evidence to support these diseases; 4) At least 2 weeks without taking PPI\u002FP-CAB; 5) Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring; 6) Capable of completing the signing of informed consent forms as required.\n\nExclusion Criteria:\n\n* 1)Gastrointestinal endoscopy suggests patients with active gastrointestinal ulcers; 2)History of malignant tumors of the digestive system (not limited to the digestive tract), inflammatory bowel disease, and pseudo or mechanical bowel obstruction in the past; 3)Previous gastrointestinal resection surgery;appendectomy and cholecystectomy within 1 year; 4)History of gastrointestinal perforation, gastrointestinal bleeding, cholangitis, and acute or chronic pancreatitis within one year; 5)Evidence suggests current gastrointestinal infections (Helicobacter pylori, acute infectious enteritis); 6)History of type I diabetes and primary hypothyroidism (the patients with normal thyroid function can be included); 7)Diagnosed lactose malabsorption, lactose intolerance, and pancreatic exocrine dysfunction; 8)History of antibiotic use within four weeks; 9)History of endoscopic examination within two weeks; 10)History of taking gastrointestinal motility promoting drugs, probiotics, and laxatives within one week; 11)On the day before the test, consume fermentable foods such as yogurt, kimchi, soy sauce, oats, beer, etc; 12)Eight hours prior to testing, without fasting; 13)Smoking and vigorous exercise two hours before and during the testing period; 14)Difficulty in exhaling due to respiratory system diseases, or inability to fast or drink for extended periods of time, resulting in inability to complete hydrogen and methane breath tests; 15)Pregnant, lactating women, or those with poor overall compliance, or other situations that researchers consider necessary to exclude.","18 Years","65 Years",{"count":50,"type":19},220,"1 Day","OBSERVATIONAL","Evaluate the prevalence of small intestinal bacterial overgrowth in patients with autoimmune gastritis (AIG) through hydrogen and methane breath testing, and determine whether there are differences in the positive rates of hydrogen and methane breath testing among the AIG group, the acid suppression group, and the control group.",[25],[56,57],"small intestinal bacterial overgrowth(SIBO)","hydrogen and methane breath testing(HMBT)","2025-04-19",{"date":60,"type":30},"2025-04-27",{"date":62,"type":30},"2025-01-06",{"date":34,"type":19},{"name":65,"class":37},"RenJi Hospital",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":38},"100583836","exploratory-study-on-the-efficacy-of-betaine-hydrochloride-in-treating-autoimmune-gastritis-100583836","NCT06881511","Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis","Inclusion Criteria:\n\n1. Patients diagnosed with autoimmune gastritis at the Second Affiliated Hospital of Zhejiang University School of Medicine, with the diagnostic criteria for autoimmune gastritis based on the article \"A real-world study on the characteristics of autoimmune gastritis: A single-center retrospective cohort in China\" published by our team in the journal Clinics and Research in Hepatology and Gastroenterology;\n2. Gastrin levels greater than 300 pmol\u002FL or a history of type 1 gastric neuroendocrine tumors or early gastric cancer treated with endoscopic submucosal dissection (ESD);\n3. Age between 18 and 80 years;\n4. Patients who have signed the informed consent form for the clinical trial.\n\nExclusion Criteria:\n\n1. Patients allergic to betaine hydrochloride;\n2. Patients with peptic ulcers;\n3. Patients with any condition other than autoimmune gastritis that causes elevated gastrin levels (e.g., gastrinoma);\n4. Patients who refuse to sign the informed consent form.","80 Years",{"count":74,"type":19},100,[22],"Autoimmune gastritis (AIG) is a chronic autoimmune disorder characterized by parietal cell destruction and oxyntic mucosal atrophy, leading to achlorhydria and intrinsic factor deficiency. These pathological changes impair iron and vitamin B12 absorption, resulting in iron-deficiency anemia, pernicious anemia, and neuropsychiatric manifestations. Notably, 4-12% of AIG patients develop type 1 gastric neuroendocrine tumors, while facing a 3-7 fold increased risk of gastric adenocarcinoma with an incidence of 0.9-9%.\n\nCurrent management of AIG is limited to iron and vitamin B12 replacement, as no disease-modifying therapies exist. The progressive hypochlorhydria reduces pepsin activity, impairs gastric motility, and promotes small intestinal bacterial overgrowth (SIBO), causing dyspeptic symptoms and micronutrient malabsorption. Furthermore, gastric hypoacidity increases N-nitroso compound formation and triggers hypergastrinemia, elevating risks for both gastric cancer and neuroendocrine tumors.\n\nThis clinical trial investigates whether betaine hydrochloride (with pepsin) supplementation can restore gastric acidity and improve clinical outcomes in AIG. We will evaluate its effects on gastrin levels, gastrointestinal symptoms, exhaled gas markers (NO, H₂S, H₂, CH₄), anemia parameters, endoscopic atrophy scores, and incidence of gastric complications (hyperplastic polyps, neuroendocrine tumors, and adenocarcinoma). The study aims to provide evidence for a potential therapeutic strategy addressing both symptoms and long-term complications of AIG.",[25],[25,79,80,81,82,83,84,85,86],"Iron-Deficiency Anemia","Stomach Neoplasms","Neuroendocrine Tumors","Betaine","Hydrochloride","Pepsin","Gastrointestinal Agents","Gastrins","2025-03-25",{"date":89,"type":30},"2025-03-30",{"date":91,"type":30},"2025-01-03",{"date":93,"type":19},"2026-12-31",{"name":95,"class":37},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":38},"100558909","the-application-of-the-pdca-management-model-in-improving-the-diagnostic-accuracy-of-aig-100558909","NCT06557252","The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG","Inclusion Criteria:\n\nEndoscopy center gastroenterologists in our hospital in 2024\n\nExclusion Criteria:\n\nDoctors who withdrew from the PDCA management midway and stopped undergoing gastroscopy.",{"count":103,"type":19},16,"Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. It can also be complicated by hyperplastic gastric polyps, gastric neuroendocrine tumors, gastric adenocarcinoma, and other diseases, making it prone to clinical misdiagnosis. As a form of gastritis in the post-Helicobacter pylori era, its detection rate has been gradually increasing with the continuous improvement of endoscopic technology in China. Applying the PDCA cycle management in disease diagnosis can significantly improve the detection rate of the disease, benefiting patients. Through the PDCA management model, this study further enhanced gastroenterologists' understanding of this disease from various aspects, aiming to improve the clinical diagnosis of autoimmune gastritis.",[25],"NOT_YET_RECRUITING","2024-08-13",{"date":109,"type":30},"2024-08-16",{"date":111,"type":19},"2024-08-15",{"date":113,"type":19},"2024-12-31",{"name":115,"class":37},"Ningbo No. 1 Hospital"]