Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial

February 23, 2026 updated by: Dazhi Xu, Fudan University

Gastric Cancer Prevention Strategies Based on Eradication of Helicobacter Pylori Subtypes at High Risk for Gastric Cancer: a Practical Cluster-randomized Controlled Trial

This study is a prospective, multicenter cluster randomized controlled trial. Additional fecal screening for high-risk SNP subtypes, in conjunction with routine Hp testing, may improve the identification of individuals at high risk for gastric cancer. Moreover, the implementation of eradication interventions in high-risk groups has the potential to significantly reduce the incidence and progression of gastric cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary study objective: To compare the five-year gastric cancer incidence between the two groups during the follow-up period and assess the impact of the eradication strategy on the prevention of gastric cancer.

Secondary study objective: 1. To compare the ten-year gastric cancer incidence between the two groups during the follow-up period and further evaluate the long-term impact of the eradication strategy on the prevention of gastric cancer. 2. To compare the "high-risk SNP subtype eradication strategy" with routine Hp management in detecting early gastric cancer: Evaluate the difference in early gastric cancer detection between the intervention group and the routine management group during follow-up. 3. To compare the "high-risk SNP subtype eradication strategy" with routine Hp management in detecting gastric precancerous lesions: Assess the difference in the detection of gastric precancerous lesions between the two groups.

Other study objective: To evaluate the impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence.

Randomization: Subjects with high-risk subtypes who met the inclusion criteria were grouped into clusters and then randomized into an intervention group and a control group.

Intervention:

  • Intervention group: Received standardized H. pylori eradication treatment recommendations provided by trial staff/physicians based on patient risk, clinical symptoms, and other factors.
  • Control group: Received standardized follow-up and routine management without treatment guidance for high-risk Hp subtypes.

Follow-up and Comparison:

The follow-up will 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 specified follow-up period.

Study Type

Interventional

Enrollment (Estimated)

4824

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tongling, China
        • People's Hospital of Tongling City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria :

  1. Age ≥ 40 years, gender is not limited.
  2. Voluntary participation with signed informed consent.
  3. No H. pylori eradication treatment received within the past 1 month.
  4. Able to complete stool sample collection and related examinations as per study requirements.
  5. Detected as high-risk by Hp subtype test.

Exclusion Criteria:

  1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
  2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
  3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
  4. Pregnant or breastfeeding women.
  5. Other conditions that the investigator deems inappropriate for participation in the study.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group (high-risk Hp subtype guidance + eradication treatment)
The guidance team, consisting of the attending physician and trial-related personnel, will conduct individualized assessments and education based on factors such as Hp infection, SNP results, gastric mucosa condition, and medical history, and provide eradication treatment recommendations.
Drug: recommendations for Hp 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.
Other Names:
  • Helicobacter pylori eradication
No Intervention: Control group (routine Hp management)
According to the routine management of HP infected patients, symptomatic relief treatment will be provided, and no intervention guidance from the 'high-risk Hp subtype guidance group' will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five-year gastric cancer incidence in both groups
Time Frame: Through study completion, an average of 5 to 10 years
To compare the incidence of gastric cancer between the two groups during the follow-up period to assess the impact of the eradication strategy on the prevention of gastric cancer.
Through study completion, an average of 5 to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ten-year gastric cancer incidence in both groups
Time Frame: Through study completion, an average of 5 to 10 years.
To compare the incidence of gastric cancer between the two groups during the follow-up period to further evaluate the long-term impact of the eradication strategy on the prevention of gastric cancer.
Through study completion, an average of 5 to 10 years.
Difference in early gastric cancer detection between the intervention group and the routine management group during follow-up
Time Frame: Through study completion, an average of 5 to 10 years.
To comparison of the "high-risk SNP subtype eradication strategy" and routine Hp management in detecting early gastric cancer.
Through study completion, an average of 5 to 10 years.
Difference in the detection of gastric precancerous lesions between the two groups
Time Frame: Through study completion, an average of 5 to 10 years.
To comparison of the "high-risk SNP subtype eradication strategy" and routine Hp management in detecting gastric precancerous lesions.
Through study completion, an average of 5 to 10 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence
Time Frame: Through study completion, an average of 5 to 10 years
To evaluate how the eradication strategy affects adherence to treatment and management of Hp infection.
Through study completion, an average of 5 to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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