Clinical trial · Interventional
A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
NCT04660123CI-TRIAL-00063562completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bismuth | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Quadruple therapy with colloidal bismuth pectin granules
- description
- colloidal bismuth pectin granules 150 mg, Selection of 2 antibiotics and 1 proton pump inhibitor based on China's fifth national consensus report on the management of H. pylori infection.All medication is taken orally, twice a day.
- interventionNames
- Drug: Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Primary outcomes (1)
- measure
- helicobacter pylori eradication
- timeFrame
- 28 days after treatment
- description
- The primary end point of this study is H.pylori eradication,established by negative \[13C\] urea breath test 28 days after the end of eradication.
Secondary outcomes (1)
- measure
- symptoms improvement rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.