Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT05014334
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18\~70,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
3. Patients are willing to receive eradication treatment.
4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion Criteria:
1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
2. Patients with contraindications or allergies to the study drug.
3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
4. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
6. Pregnant or lactating women.
7. Underwent upper gastrointestinal Surgery.
8. Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
9. Patients have symptom of dysphagia.
10. Evidence of bleeding or iron efficiency anemia.
11. A history of malignancy.
12. Drug or alcohol abuse history in the past 1 year.
13. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
14. Patients who has psychological problem or poor compliance.
15. Enrolled in other clinical trials in the past 3 months.
16. Refuse to sign informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05014334
Study Brief:
Protocol Section:
NCT05014334