Recruiting

Betaine Hydrochloride for Autoimmune Gastritis Patients

What is being tested

No intervention (Control Group)

+ Oral betaine hydrochloride (2 capsules, 3 times daily)

OtherDietary Supplement

Who is being recruted

Iron Deficiencies+19

+ Anemia

+ Anemia, Hypochromic

From 18 to 80 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2025

See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Study ContactJianshan Mao, MD, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2025

Actual date on which the first participant was enrolled.

Autoimmune gastritis (AIG) is a condition where the body's immune system mistakenly attacks the stomach lining, leading to a lack of stomach acid and important nutrients like iron and vitamin B12. This can cause symptoms such as anemia and digestive issues, and increases the risk of stomach tumors. Currently, there is no specific treatment for AIG, so this study aims to see if betaine hydrochloride, a substance that might help increase stomach acidity, can improve symptoms and reduce risks associated with AIG. The target group for this study includes adults diagnosed with AIG who meet certain medical criteria. Participants in this study are divided into two groups. One group will receive oral betaine hydrochloride capsules three times a day, while the other group will not receive any treatment and will serve as a comparison. Researchers will look at changes in various health markers, including stomach acid-related symptoms, nutrient levels, and the presence of stomach tumors over time. Data is gathered through medical tests, questionnaires, and endoscopies. The study is carefully monitored for any potential adverse effects, which will be reported to ensure safety. This research aims to provide new insights into a potential treatment option for those suffering from AIG.

Official TitleExploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis

NCT06881511

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Study ContactJianshan Mao, MD, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesAnemiaAnemia, HypochromicDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNutritional and Metabolic DiseasesStomach DiseasesStomach NeoplasmsNeuroectodermal TumorsNeuroendocrine TumorsAnemia, Iron-DeficiencyIron Metabolism Disorders

Criteria

4 inclusion criteria required to participate

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.

4 exclusion criteria prevent from participating

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Patients in this group will not receive any intervention and will only undergo regular follow-up and monitoring.

Group II

Experimental

Patients in this group will receive oral betaine hydrochloride (with pepsin) .

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, ChinaOpen The Second Affiliated Hospital, Zhejiang University School of Medicine in Google Maps

Recruiting

One Study Center