Clinical trial · Interventional
Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Gastritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (Control Group) | Other | — | UNRESOLVED |
| Oral betaine hydrochloride (2 capsules, 3 times daily) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group A: Observation Only (Control Group)
- description
- Patients in this group will not receive any intervention and will only undergo regular follow-up and monitoring.
- interventionNames
- Other: No intervention (Control Group)
- type
- EXPERIMENTAL
- label
- Group B: Betaine Hydrochloride Supplementation
- description
- Patients in this group will receive oral betaine hydrochloride (with pepsin) .
- interventionNames
- Dietary Supplement: Oral betaine hydrochloride (2 capsules, 3 times daily)
Primary outcomes (2)
- measure
- Serum Gastrin Levels
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDSong M, Camargo MC, Katki HA, Weinstein SJ, Mannisto S, Albanes D, Surcel HM, Rabkin CS. Association of Antiparietal Cell and Anti-Intrinsic Factor Antibodies With Risk of Gastric Cancer. JAMA Oncol. 2022 Feb 1;8(2):268-274. doi: 10.1001/jamaoncol.2021.5395. PMID 34913949
- BACKGROUNDRossi RE, Elvevi A, Sciola V, Mandarino FV, Danese S, Invernizzi P, Massironi S. Paradoxical association between dyspepsia and autoimmune chronic atrophic gastritis: Insights into mechanisms, pathophysiology, and treatment options. World J Gastroenterol. 2023 Jun 21;29(23):3733-3747. doi: 10.3748/wjg.v29.i23.3733. PMID 37398891
- BACKGROUNDSingh S, Chakole S, Agrawal S, Shetty N, Prasad R, Lohakare T, Wanjari M, Yelne S. A Comprehensive Review of Upper Gastrointestinal Symptom Management in Autoimmune Gastritis: Current Insights and Future Directions. Cureus. 2023 Aug 13;15(8):e43418. doi: 10.7759/cureus.43418. eCollection 2023 Aug. PMID 37706145
- BACKGROUNDOsmola M, Chapelle N, Vibet MA, Bigot-Corbel E, Masson D, Hemont C, Jirka A, Blin J, Tougeron D, Moussata D, Lamarque D, Josien R, Mosnier JF, Martin J, Matysiak-Budnik T. Iron and Vitamin B12 Deficiency in Patients with Autoimmune Gastritis and Helicobacter pylori Gastritis: Results from a Prospective Multicenter Study. Dig Dis. 2024;42(2):145-153. doi: 10.1159/000535206. Epub 2024 Jan 10. PMID 38198775
- BACKGROUNDJove A, Lin C, Hwang JH, Balasubramanian V, Fernandez-Becker NQ, Huang RJ. Serum Gastrin Levels Are Associated With Prevalent Neuroendocrine Tumors in Autoimmune Metaplastic Atrophic Gastritis. Am J Gastroenterol. 2025 May 1;120(5):1140-1143. doi: 10.14309/ajg.0000000000003235. Epub 2024 Nov 26. PMID 39588964
- BACKGROUNDChen C, Yang Y, Li P, Hu H. Incidence of Gastric Neoplasms Arising from Autoimmune Metaplastic Atrophic Gastritis: A Systematic Review and Case Reports. J Clin Med. 2023 Jan 30;12(3):1062. doi: 10.3390/jcm12031062.