RecruitingNot ApplicableNCT06881511

Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

100 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether betaine hydrochloride — a supplement that increases stomach acid — can help people with autoimmune gastritis. This condition causes the immune system to attack stomach cells, leading to low stomach acid, poor nutrient absorption (especially B12 and iron), and sometimes precancerous changes. Low stomach acid is a core problem, and this supplement may help compensate for it. **You may be eligible if:** - You have been diagnosed with autoimmune gastritis at the study hospital - Your gastrin level (a hormone that goes up when stomach acid is low) is above 300 pmol/L - OR you have a history of type 1 stomach neuroendocrine tumors or early gastric cancer treated with endoscopic surgery - You are between 18 and 80 years old **You may NOT be eligible if:** - You are allergic to betaine hydrochloride - You have peptic ulcers or other conditions that are worsened by stomach acid - You are outside the 18–80 age range - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention (Control Group)

Patients in this group will receive standard care and undergo regular follow-up and monitoring without any additional treatment.

DIETARY_SUPPLEMENTOral 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.


Locations(1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06881511


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