Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk

NCT ID: NCT06943794

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4824 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2030-12-30

Brief Summary

This study is a prospective, multicenter randomized controlled study. Additional fecal screening for Hp-specific SNP mutation sites on top of routine Hp testing may improve the identification of people at high risk for gastric cancer, and the treatment of eradication interventions in high-risk groups can significantly reduce the incidence or risk of progression of gastric cancer.

Detailed Description

Primary study objective: To evaluate whether H. pylori eradication therapy can reduce the risk of gastric mucosal lesion progression or gastric cancer in a subgroup of asymptomatic H. pylori-positive subjects with high-risk SNP loci.

The secondary objectives of the study are: 1. to compare the difference between the "fecal Hp high-risk subtype eradication" strategy and routine Hp testing in detecting early gastric cancer or precancerous lesions (e.g., gastric mucosal atypia, intestinal metaplasia, etc.). 2. to evaluate the impact of the "fecal high-risk subtype eradication" strategy on treatment and management adherence. 3. to assess the effectiveness of the "Hp high-risk subtype eradication" strategy in reducing the risk of gastric cancer. Evaluate the impact of the "fecal high-risk Hp subtype eradication" strategy on adherence to treatment and management. 3. Analyze the improvement of gastric mucosal atrophy, intestinal metaplasia, and inflammation after eradication treatment in the "high-risk Hp subtype" population.

People meeting the inclusion criteria were recruited from multiple centers. Randomization: Subjects with high-risk subtypes who met the inclusion criteria were randomized into an intervention group and a control group. INTERVENTION: Intervention group: received standardized H. pylori eradication treatment recommendations given by trial staff/physicians based on patient risk, clinical symptoms, etc. Control group: received standardized follow-up and routine management without treatment guidance for high-risk Hp subtypes. Follow-up and comparison: to compare the differences between the two groups in terms of the detection rate of gastric cancer or precancerous lesions, the incidence (or progression) of gastric cancer, patient adherence, and complications within a certain follow-up period.

Conditions

Gastric (Stomach) Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Treatment group (high-risk Hp subtype guidance + eradication treatment)

Group Type: EXPERIMENTAL

recommendations for eradication treatment

Intervention Type: DRUG

A high-risk Hp subtype guidance group consisting of the receiving physician + trial-related personnel conducts individualized assessment based on Hp infection, SNP test results, gastric mucosa condition, medical history and other factors, and provides subjects with medical explanations and recommendations for eradication treatment.

Eradication group protocol: standard quadruple therapy for H. pylori eradication program (PPI + bismuth + two antibiotics)

1. Omeprazole (or esomeprazole): 20mg, 2 times/day

2. Bismuth citrate: 220mg, 2 times/day

3. Metronidazole: 400mg, 3 times/day

4. Tetracycline: 500mg, 3 times/day

5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test.

Control group (routine Hp management)

according to the routine management of asymptomatic infected patients, will not be given the guidance intervention of high-risk Hp subtype guidance group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

recommendations for eradication treatment

A high-risk Hp subtype guidance group consisting of the receiving physician + trial-related personnel conducts individualized assessment based on Hp infection, SNP test results, gastric mucosa condition, medical history and other factors, and provides subjects with medical explanations and recommendations for eradication treatment.

Eradication group protocol: standard quadruple therapy for H. pylori eradication program (PPI + bismuth + two antibiotics)

1. Omeprazole (or esomeprazole): 20mg, 2 times/day

2. Bismuth citrate: 220mg, 2 times/day

3. Metronidazole: 400mg, 3 times/day

4. Tetracycline: 500mg, 3 times/day

5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. Volunteer to participate in this study and sign an informed consent form.

3. Have not received H. pylori eradication treatment in the past 1 month.

4. Able to complete stool sample collection and related examinations according to the requirements of the study.

5. Have been detected as high risk by Hp subtype test.

6. Have no obvious clinical symptoms, or have mild symptoms that do not meet the current clinical guidelines for "eradication therapy".

7. Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.

Exclusion Criteria

1. Negative Hp test.

2. Previous diagnosis of gastric cancer or other malignant tumors.

3. Severe systemic diseases or comorbidities (hepatic, renal, cardiac insufficiency, etc.) that do not tolerate gastroscopy or study procedures.

4. Use of proton pump inhibitors, antibiotics, or other drugs that affect Hp detection or therapeutic effects within 3 months.

5. Pregnant or lactating women.

6. Other conditions that the investigator considers inappropriate for participation in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

Director of the gastric surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Dazhi Xu, Doctor

Role: CONTACT

xudzh@shca.org.cn

08618121299796

Other Identifiers

2025RCT

Identifier Type: -

Identifier Source: org_study_id