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 formation and triggers hypergastrinemia, elevating risks for both gastric cancer and neuroendocrine tumors.
This 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.
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;
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);
Age between 18 and 80 years;
Patients who have signed the informed consent form for the clinical trial.
Patients allergic to betaine hydrochloride;
Patients with peptic ulcers;
Patients with any condition other than autoimmune gastritis that causes elevated gastrin levels (e.g., gastrinoma);
Patients who refuse to sign the informed consent form.
Parallel
No intervention (Control Group)
Other interventionPatients in this group will receive standard care and undergo regular follow-up and monitoring without any additional treatment.
Oral betaine hydrochloride (2 capsules, 3 times daily)
Dietary supplementOral betaine hydrochloride (with pepsin). Patients will take 2 capsules (648 mg per capsule) of betaine hydrochloride, 3 times daily with meals.
Serum Gastrin Levels
Comparison of the differences in serum gastrin levels before and after the trial within and between groups.
Gastrointestinal Symptom Scores
Gastrointestinal symptom scores will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS) . Comparison of the differences in gastrointestinal symptom scores before and after the trial within and between groups.
Exhaled Gas Markers (NO, H2S, H2, and CH4)
Comparison of the differences in exhaled gas marker levels (NO, H2S, H2, and CH4) before and after the trial within and between groups.
Iron Deficiency Anemia Indicators (Serum Iron, Ferritin, Hemoglobin)
Comparison of the differences in iron deficiency anemia indicators (serum iron, ferritin, and hemoglobin) before and after the trial within and between groups.
AIG Atrophy Score and Incidence of Gastric Complications
Comparison of the differences in AIG atrophy scores and the incidence of gastric complications (hyperplastic polyps, neuroendocrine tumors, and gastric cancer) before and after the trial within and between groups.
Click on the lead sponsor to view all of their trials.
