Last updated: January 29, 2023
Sponsor: Xijing Hospital of Digestive Diseases
Overall Status: Completed
Phase
4
Condition
Heartburn (Pediatric)
Gastrointestinal Diseases And Disorders
Gastric Cancer
Treatment
N/AClinical Study ID
NCT04697186
KY20202119
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 18~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infectionwho did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptivemethods during and 30 days after the trial.
Exclusion
Exclusion Criteria:
- Patients are excluded if they have previously used antibiotics to eradicate adequatelyrecorded infection with H. pylori.
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severeor unstable cardiopulmonary or endocrine diseases.
- 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).
- Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- Patients with moderate to severe dysplasia or high degree of intraepithelialneoplasia.
- Patients have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants,platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- Patients who has psychological problem or poor compliance.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Study Design
Total Participants: 524
Study Start date:
January 07, 2021
Estimated Completion Date:
December 20, 2021
Study Description
Connect with a study center
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi 710032
ChinaSite Not Available

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