Using betaine hydrochloride to treat autoimmune gastritis
Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis
This study is testing whether betaine hydrochloride can help people with autoimmune gastritis feel better and reduce their health risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06881511 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of betaine hydrochloride in patients diagnosed with autoimmune gastritis, a condition characterized by the destruction of gastric parietal cells leading to various complications such as anemia and increased cancer risk. Participants will receive either betaine hydrochloride or no intervention, and their health outcomes will be monitored to assess the treatment's effectiveness. The study aims to provide a potential disease-modifying therapy for a condition that currently lacks effective treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with autoimmune gastritis and exhibiting elevated gastrin levels or a history of gastric neuroendocrine tumors.
Not a fit: Patients with allergies to betaine hydrochloride or other conditions causing elevated gastrin levels will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve symptoms and reduce complications associated with autoimmune gastritis.
How similar studies have performed: While there is limited research on betaine hydrochloride for autoimmune gastritis specifically, the approach of using dietary supplements for gastrointestinal conditions has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Jianshan Mao, MD, PhD
- Email: jshmao@zju.edu.cn
- Phone: +86-571-8778-3540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.