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Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis

RecruitingNAAges 18 Years - 80 YearsAllSecond Affiliated Hospital, Zhejiang University, …
NCT06881511 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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%. Current 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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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; 2. Gastrin levels greater than 300 pmol/L or a history of type 1 gastric neuroendocrine tumors or early gastric cancer treated with endoscopic submucosal dissection (ESD); 3. Age between 18 and 80 years; 4. Patients who have signed the informed consent form for the clinical trial. Exclusion Criteria: 1. Patients allergic to betaine hydrochloride; 2. Patients with peptic ulcers; 3. Patients with any condition other than autoimmune gastritis that causes elevated gastrin levels (e.g., gastrinoma); 4. Patients who refuse to sign the informed consent form.
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What it tests

  • No intervention (Control Group)
  • Oral betaine hydrochloride (2 capsules, 3 times daily)
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Where

1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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