Status:
NOT_YET_RECRUITING
Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk
Lead Sponsor:
Fudan University
Conditions:
Gastric (Stomach) Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 peopl...
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Volunteer to participate in this study and sign an informed consent form.
- Have not received H. pylori eradication treatment in the past 1 month.
- Able to complete stool sample collection and related examinations according to the requirements of the study.
- Have been detected as high risk by Hp subtype test.
- Have no obvious clinical symptoms, or have mild symptoms that do not meet the current clinical guidelines for "eradication therapy".
- Within 90 days, the gastroscopy and/or pathological results confirm the absence of gastric cancer.
Exclusion
- Negative Hp test.
- Previous diagnosis of gastric cancer or other malignant tumors.
- Severe systemic diseases or comorbidities (hepatic, renal, cardiac insufficiency, etc.) that do not tolerate gastroscopy or study procedures.
- Use of proton pump inhibitors, antibiotics, or other drugs that affect Hp detection or therapeutic effects within 3 months.
- Pregnant or lactating women.
- Other conditions that the investigator considers inappropriate for participation in this trial.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
4824 Patients enrolled
Trial Details
Trial ID
NCT06943794
Start Date
December 1 2025
End Date
December 30 2030
Last Update
June 24 2025
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