Autoimmune GastritisNCT06881511
Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis
A study testing Oral betaine hydrochloride (2 capsules, 3 times daily) in people with Autoimmune Gastritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Autoimmune gastritis (AIG) is a chronic autoimmune disorder characterized by parietal cell destruction and oxyntic mucosal atrophy, leading to achlorhydria and intrinsic factor deficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Gastritis
- What is being tested?
- Oral betaine hydrochloride (2 capsules, 3 times daily)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
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.
Read the detailed description
Autoimmune gastritis (AIG) is a chronic progressive autoimmune disorder characterized by the destruction of gastric parietal cells, leading to atrophy of the acid-secreting gastric mucosa. The loss of parietal cells results in gastric acid deficiency and intrinsic factor deficiency, which in turn impairs the absorption of iron and vitamin B12, leading to clinical manifestations such as iron deficiency anemia, pernicious anemia, and neuropsychiatric symptoms. Studies indicate that 4-12% of AIG patients develop type 1 gastric neuroendocrine tumors (NETs), and these patients also face a 3-7 times higher risk of gastric adenocarcinoma, with an incidence rate ranging from 0.9% to 9%.
Currently, there are no anti-inflammatory, immunosuppressive, or biologic therapies available for AIG. Standard treatment involves iron and vitamin B12 supplementation. Due to progressive parietal cell destruction, AIG patients exhibit a hypochlorhydric state, which reduces pepsin activity, impairs gastric motility, and may lead to small intestinal bacterial overgrowth (SIBO), often causing symptoms such as dyspepsia. Additionally, low gastric acid levels can interfere with the absorption of trace elements like iron and calcium. Insufficient gastric acid also promotes bacterial overgrowth in the stomach and increases N-nitroso compounds, elevating the risk of gastric cancer. Furthermore, gastric hypochlorhydria triggers a feedback mechanism that stimulates gastrin secretion from antral G cells, resulting in hypergastrinemia, which increases the risk of neuroendocrine tumors. Supplementation with betaine hydrochloride (with pepsin) can lower gastric pH in AIG patients, restore gastric acidity, improve protein digestion, alleviate dyspeptic symptoms, enhance the absorption of vitamins and minerals, correct gastric dysbiosis and SIBO, and reduce the risk of gastric cancer and neuroendocrine tumors.
This study aims to evaluate the effects of betaine hydrochloride (with pepsin) on gastrin levels, gastrointestinal symptoms, exhaled gas markers (NO, H2S, H2, and CH4), iron deficiency anemia parameters, AIG atrophy scores, and the incidence of gastric complications (hyperplastic polyps, neuroendocrine tumors, and gastric cancer). The study is divided into two groups: Group A (follow-up only, serving as the control group) and Group B (oral betaine hydrochloride). The study adopts a non-randomized, open-label, parallel-controlled design, where participants choose either the experimental group (oral betaine) or the control group (follow-up only) based on their preference. Both groups will be followed in parallel, and outcome differences will be compared, supplemented by within-group pre- and post-intervention analyses.
The study population consists of AIG patients diagnosed at the Second Affiliated Hospital of Zhejiang University School of Medicine. The diagnostic criteria for AIG are based on our team's published article in Clinics and Research in Hepatology and Gastroenterology: "A real-world study on the characteristics of autoimmune gastritis: A single-center retrospective cohort in China." Inclusion criteria include: serum gastrin levels >300 pmol/L or a history of type 1 gastric NETs or early gastric cancer treated with endoscopic submucosal dissection (ESD), age between 18 and 80 years, and signed informed consent. Exclusion criteria include: allergy to betaine hydrochloride, presence of peptic ulcers, other conditions causing elevated gastrin levels, and refusal to sign informed consent.
Group A (control group) will undergo follow-up only without intervention, while Group B will receive oral betaine hydrochloride (2 capsules three times daily with meals). The primary outcomes include changes in serum gastrin levels and improvements in the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes include changes in iron deficiency anemia markers (serum iron, ferritin, hemoglobin), exhaled gas markers (NO, H2S, H2, CH4), AIG atrophy scores, and the incidence of gastric complications (hyperplastic polyps, NETs, and gastric cancer).
Data will be collected through questionnaires, laboratory tests, endoscopy, and pathological records, with propensity score matching (PSM) used to adjust for baseline differences. The study has been approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine. Adverse events will be monitored regularly, and serious adverse events will be reported promptly to the ethics committee and regulatory authorities.
This study will provide critical evidence on the efficacy and safety of betaine hydrochloride in treating AIG, exploring a simple, cost-effective therapeutic approach to alleviate symptoms and reduce the risk of severe complications.
- Conditions
- Autoimmune Gastritis
- Being tested
- No intervention (Control Group), Oral betaine hydrochloride (2 capsules, 3 times daily)
- Keywords
- Autoimmune Gastritis, Iron-Deficiency Anemia, Stomach Neoplasms, Neuroendocrine Tumors, Betaine, Hydrochloride, Pepsin, Gastrointestinal Agents, Gastrins
- Medical subject headings
- Anemia, Iron-Deficiency, Stomach Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (Control Group)Other
Patients 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 supplement
Oral betaine hydrochloride (with pepsin). Patients will take 2 capsules (648 mg per capsule) of betaine hydrochloride, 3 times daily with meals.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Observation Only (Control Group) | Other | Patients in this group will not receive any intervention and will only undergo regular follow-up and monitoring. Receives: Other: No intervention (Control Group) |
| Group B: Betaine Hydrochloride Supplementation | Experimental | Patients in this group will receive oral betaine hydrochloride (with pepsin) . Receives: Dietary Supplement: Oral betaine hydrochloride (2 capsules, 3 times daily) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Gastrin Levels
Comparison of the differences in serum gastrin levels before and after the trial within and between groups.
Measured: Baseline, 1 month, 3 months, 7 months, and 12 months.
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.
Measured: Baseline, 1 month, 3 months, 7 months, and 12 months.
Secondary outcomes (3)
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.
Measured: Baseline, 1 month, and 12 months.
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.
Measured: Baseline, 1 month, and 12 months.
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.
Measured: Baseline and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start3 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Autoimmune GastritisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will employ a linear mixed-effects model to analyze changes in primary outcomes (GSRS scores and serum gastrin levels), with the intervention effect evaluated through group-by-time interactions. For secondary outcomes, continuous variables will be analyzed using multiple linear regression, while categorical variables will be analyzed using logistic regression or Cox proportional hazards models. All models will adjust for baseline differences (via propensity score matching) and potential confounders. Model assumptions will be validated through residual analysis and diagnostic plots. Sensitivity analyses will include per-protocol vs intention-to-treat comparisons and alternative propensity score methods. Data analysis will be performed using R (version 4.0) or SAS (version 9.4).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881511
- Sponsor's protocol ID
- 2024-0911
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song 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.
PubMed 34913949Rossi 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.
PubMed 37398891Singh 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.
PubMed 37706145Osmola 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.
PubMed 38198775Jove 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.
PubMed 39588964Chen 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.
PubMed 36769710Gomez Cifuentes JD, Sparkman J, Graham DY. Management of upper gastrointestinal symptoms in patients with autoimmune gastritis. Curr Opin Gastroenterol. 2022 Nov 1;38(6):600-606. doi: 10.1097/MOG.0000000000000878. Epub 2022 Sep 9.
PubMed 36165039Lenti MV, Rugge M, Lahner E, Miceli E, Toh BH, Genta RM, De Block C, Hershko C, Di Sabatino A. Autoimmune gastritis. Nat Rev Dis Primers. 2020 Jul 9;6(1):56. doi: 10.1038/s41572-020-0187-8.
PubMed 32647173Taylor L, McCaddon A, Wolffenbuttel BHR. Creating a Framework for Treating Autoimmune Gastritis-The Case for Replacing Lost Acid. Nutrients. 2024 Feb 27;16(5):662. doi: 10.3390/nu16050662.
PubMed 38474790Chen Y, Ji X, Zhao W, Lin J, Xie S, Xu J, Mao J. A real-world study on the characteristics of autoimmune gastritis: A single-center retrospective cohort in China. Clin Res Hepatol Gastroenterol. 2025 Apr;49(4):102556. doi: 10.1016/j.clinre.2025.102556. Epub 2025 Feb 15.
PubMed 39961485
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis
- ClinicalTrials.gov ID
- NCT06881511
- Acronym / sponsor ID
- 2024-0911
- Conditions
- Autoimmune Gastritis
- Keywords
- Autoimmune Gastritis, Iron-Deficiency Anemia, Stomach Neoplasms, Neuroendocrine Tumors, Betaine, Hydrochloride, Pepsin, Gastrointestinal Agents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autoimmune gastritis (AIG) is a chronic progressive autoimmune disorder characterized by the destruction of gastric parietal cells, leading to atrophy of the acid-secreting gastric mucosa. The loss of parietal cells results in gastric acid deficiency and intrinsic factor deficiency, which in turn impairs the absorption of iron and vitamin B12, leading to clinical manifestations such as iron deficiency anemia, pernicious anemia, and neuropsychiatric symptoms. Studies indicate that 4-12% of AIG patients develop type 1 gastric neuroendocrine tumors (NETs), and these patients also face a 3-7 times higher risk of gastric adenocarcinoma, with an incidence rate ranging from 0.9% to 9%.
Currently, there are no anti-inflammatory, immunosuppressive, or biologic therapies available for AIG. Standard treatment involves iron and vitamin B12 supplementation. Due to progressive parietal cell destruction, AIG patients exhibit a hypochlorhydric state, which reduces pepsin activity, impairs gastric motility, and may lead to small intestinal bacterial overgrowth (SIBO), often causing symptoms such as dyspepsia. Additionally, low gastric acid levels can interfere with the absorption of trace elements like iron and calcium. Insufficient gastric acid also promotes bacterial overgrowth in the stomach and increases N-nitroso compounds, elevating the risk of gastric cancer. Furthermore, gastric hypochlorhydria triggers a feedback mechanism that stimulates gastrin secretion from antral G cells, resulting in hypergastrinemia, which increases the risk of neuroendocrine tumors. Supplementation with betaine hydrochloride (with pepsin) can lower gastric pH in AIG patients, restore gastric acidity, improve protein digestion, alleviate dyspeptic symptoms, enhance the absorption of vitamins and minerals, correct gastric dysbiosis and SIBO, and reduce the risk of gastric cancer and neuroendocrine tumors.
This study aims to evaluate the effects of betaine hydrochloride (with pepsin) on gastrin levels, gastrointestinal symptoms, exhaled gas markers (NO, H2S, H2, and CH4), iron deficiency anemia parameters, AIG atrophy scores, and the incidence of gastric complications (hyperplastic polyps, neuroendocrine tumors, and gastric cancer). The study is divided into two groups: Group A (follow-up only, serving as the control group) and Group B (oral betaine hydrochloride). The study adopts a non-randomized, open-label, parallel-controlled design, where participants choose either the experimental group (oral betaine) or the control group (follow-up only) based on their preference. Both groups will be followed in parallel, and outcome differences will be compared, supplemented by within-group pre- and post-intervention analyses.
The study population consists of AIG patients diagnosed at the Second Affiliated Hospital of Zhejiang University School of Medicine. The diagnostic criteria for AIG are based on our team's published article in Clinics and Research in Hepatology and Gastroenterology: "A real-world study on the characteristics of autoimmune gastritis: A single-center retrospective cohort in China." Inclusion criteria include: serum gastrin levels >300 pmol/L or a history of type 1 gastric NETs or early gastric cancer treated with endoscopic submucosal dissection (ESD), age between 18 and 80 years, and signed informed consent. Exclusion criteria include: allergy to betaine hydrochloride, presence of peptic ulcers, other conditions causing elevated gastrin levels, and refusal to sign informed consent.
Group A (control group) will undergo follow-up only without intervention, while Group B will receive oral betaine hydrochloride (2 capsules three times daily with meals). The primary outcomes include changes in serum gastrin levels and improvements in the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes include changes in iron deficiency anemia markers (serum iron, ferritin, hemoglobin), exhaled gas markers (NO, H2S, H2, CH4), AIG atrophy scores, and the incidence of gastric complications (hyperplastic polyps, NETs, and gastric cancer).
Data will be collected through questionnaires, laboratory tests, endoscopy, and pathological records, with propensity score matching (PSM) used to adjust for baseline differences. The study has been approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine. Adverse events will be monitored regularly, and serious adverse events will be reported promptly to the ethics committee and regulatory authorities.
This study will provide critical evidence on the efficacy and safety of betaine hydrochloride in treating AIG, exploring a simple, cost-effective therapeutic approach to alleviate symptoms and reduce the risk of severe complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will employ a linear mixed-effects model to analyze changes in primary outcomes (GSRS scores and serum gastrin levels), with the intervention effect evaluated through group-by-time interactions. For secondary outcomes, continuous variables will be analyzed using multiple linear regression, while categorical variables will be analyzed using logistic regression or Cox proportional hazards models. All models will adjust for baseline differences (via propensity score matching) and potential confounders. Model assumptions will be validated through residual analysis and diagnostic plots. Sensitivity analyses will include per-protocol vs intention-to-treat comparisons and alternative propensity score methods. Data analysis will be performed using R (version 4.0) or SAS (version 9.4).
| Arm | Type | Receives |
|---|---|---|
| Group A: Observation Only (Control Group) | Other | Other: No intervention (Control Group)Patients in this group will not receive any intervention and will only undergo regular follow-up and monitoring. |
| Group B: Betaine Hydrochloride Supplementation | Experimental | Dietary Supplement: Oral betaine hydrochloride (2 capsules, 3 times daily)Patients in this group will receive oral betaine hydrochloride (with pepsin) . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (Control Group)Patients in this group will receive standard care and undergo regular follow-up and monitoring without any additional treatment. | Other | Group A: Observation Only (Control Group) |
| Oral betaine hydrochloride (2 capsules, 3 times daily)Oral betaine hydrochloride (with pepsin). Patients will take 2 capsules (648 mg per capsule) of betaine hydrochloride, 3 times daily with meals. | Dietary supplement | Group B: Betaine Hydrochloride Supplementation |
Primary outcome
Serum Gastrin Levels
Time frame: Baseline, 1 month, 3 months, 7 months, and 12 months.
Comparison of the differences in serum gastrin levels before and after the trial within and between groups.
Gastrointestinal Symptom Scores
Time frame: Baseline, 1 month, 3 months, 7 months, and 12 months.
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.
3 secondary outcomes
Exhaled Gas Markers (NO, H2S, H2, and CH4)
Time frame: Baseline, 1 month, and 12 months.
Iron Deficiency Anemia Indicators (Serum Iron, Ferritin, Hemoglobin)
Time frame: Baseline, 1 month, and 12 months.
AIG Atrophy Score and Incidence of Gastric Complications
Time frame: Baseline and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 34913949Song 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.
- Background: PubMed 37398891Rossi 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.
- Background: PubMed 37706145Singh 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.
- Background: PubMed 38198775Osmola 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.
- Background: PubMed 39588964Jove 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.
- Background: PubMed 36769710Chen 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.
- Background: PubMed 36165039Gomez Cifuentes JD, Sparkman J, Graham DY. Management of upper gastrointestinal symptoms in patients with autoimmune gastritis. Curr Opin Gastroenterol. 2022 Nov 1;38(6):600-606. doi: 10.1097/MOG.0000000000000878. Epub 2022 Sep 9.
- Background: PubMed 32647173Lenti MV, Rugge M, Lahner E, Miceli E, Toh BH, Genta RM, De Block C, Hershko C, Di Sabatino A. Autoimmune gastritis. Nat Rev Dis Primers. 2020 Jul 9;6(1):56. doi: 10.1038/s41572-020-0187-8.
- Background: PubMed 38474790Taylor L, McCaddon A, Wolffenbuttel BHR. Creating a Framework for Treating Autoimmune Gastritis-The Case for Replacing Lost Acid. Nutrients. 2024 Feb 27;16(5):662. doi: 10.3390/nu16050662.
- Background: PubMed 39961485Chen Y, Ji X, Zhao W, Lin J, Xie S, Xu J, Mao J. A real-world study on the characteristics of autoimmune gastritis: A single-center retrospective cohort in China. Clin Res Hepatol Gastroenterol. 2025 Apr;49(4):102556. doi: 10.1016/j.clinre.2025.102556. Epub 2025 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral betaine hydrochloride (2 capsules, 3 times daily) in people with Autoimmune Gastritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianshan Mao, MD, PhD (+86-571-8778-3540, jshmao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Gastrin Levels (time frame: Baseline, 1 month, 3 months, 7 months, and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06881511, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.