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

NCT06943794 | Not Yet Recruiting

• 1 other identifier: 2025RCT
• Study Type: interventional
• Target: 4,824
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric (Stomach) Cancer

Outcome Measures

Primary Outcomes (1)

• Five-year gastric cancer incidence in both groups

  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 Outcomes (3)

• Ten-year gastric cancer incidence in both groups

  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

  Through study completion, an average of 5 to 10 years.

• Difference in the detection of gastric precancerous lesions between the two groups

  Through study completion, an average of 5 to 10 years.

Other Outcomes (1)

• Impact of the "high-risk Hp subtype eradication" strategy on treatment and management adherence

  Through study completion, an average of 5 to 10 years

Study Arms (2)

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

EXPERIMENTAL

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

Control group (routine Hp management)

NO INTERVENTION

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.

Interventions

recommendations for Hp eradication treatment 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.

Also known as: Helicobacter pylori eradication

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
• 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.
• Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
• Pregnant or breastfeeding women.
• Other conditions that the investigator deems inappropriate for participation in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

People's Hospital of Tongling City

Tongling, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Dazhi Xu, Doctor

CONTACT

086-18121299796; xudzh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the gastric surgery department

Model Details: Treatment group (high-risk Hp subtype guidance + 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. Follow-up: Annual review of Hp infection status and assessment of the progression of gastric mucosal lesions.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 24, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)