Overview

A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication

Status:
Enrolling by invitation
Trial end date:
2021-12-30
Target enrollment:
0
Participant gender:
All
Summary
To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Treatments:
Bismuth
Criteria
Inclusion Criteria:

1. Age between 18~75,both gender.

2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.

3. Patients are willing to receive eradication treatment.

4. Women are eligible if they are not pregnant or nursing, and if they are of
childbearing potential they are required to use medically acceptable contraception for
the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Contraindications to study drugs.

2. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.

3. 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).

4. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.

5. Pregnant or lactating women.

6. Underwent upper gastrointestinal Surgery.

7. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of
dysphagia.

8. Evidence of bleeding or iron efficiency anemia.

9. A history of malignancy.

10. Drug or alcohol abuse history in the past 1 year.

11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants,
platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

12. Patients who has psychological problem or poor compliance.

13. Enrolled in other clinical trials in the past 3 months.

14. Refuse to sign informed consent.