Methods for treating high gastrin levels in autoimmune gastritis patients
Safety and Efficacy Study of Betaine Hydrochloride in Treating Hypergastrinemia in Patients With Autoimmune Gastritis.
NA · The First Affiliated Hospital of Zhengzhou University · NCT06272500
This study is testing different treatments for people with autoimmune gastritis to see if they can help lower high gastrin levels and improve related symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University (other) |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06272500 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates various treatment methods for patients diagnosed with autoimmune atrophic gastritis, focusing on the management of hypergastrinemia. Participants will receive either a placebo, a compound digestive enzyme capsule, or Betaine hydrochloride to assess the efficacy of these interventions. The study aims to evaluate the impact of these treatments on gastrin levels and associated symptoms. The trial will adhere to specific diagnostic criteria and include a thorough informed consent process for all participants.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with autoimmune atrophic gastritis who meet the specified inclusion criteria.
Not a fit: Patients with conditions such as gastric ulcers, gastroesophageal reflux disease, or those allergic to Betaine hydrochloride may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients suffering from autoimmune gastritis and related complications.
How similar studies have performed: While there is limited data on similar approaches, the study aims to explore novel treatment methods for a condition that currently lacks effective management strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 1) Patients diagnosed with autoimmune atrophic gastritis at the First Affiliated Hospital of Zhengzhou University, using the diagnostic criteria from the "Guidelines for the Diagnosis and Treatment of Chronic Gastritis in China (2022, Shanghai)" for the diagnosis of atrophic gastritis, combined with serum gastrin, PCA, or IFA for the diagnosis of autoimmune atrophic gastritis. 2\) Patients who have signed the informed consent form for the clinical trial. Exclusion Criteria: * 1\) Patients with Betaine hydrochloride allergies. 2) Patients with gastric ulcers, gastroesophageal reflux disease, or cholelithiasis, as the administration of acid agents may worsen the condition or cause discomfort. 3\) Patients with gastrinomas or other conditions that can cause elevated gastrin levels, apart from autoimmune atrophic gastritis. 4\) Patients who are unable to provide informed consent or sign the informed consent form.
Where this trial is running
Zhengzhou, Henan
- First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
Study contacts
- Study coordinator: Jianning Yao, Dr.
- Email: rjyy@zzu.edu.cn
- Phone: 13733183434
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.
Conditions: Autoimmune Gastritis