Clinical trial · Interventional
Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies
Comparison of Efficacy of Bismuth Potassium Citrate, Pectin Bismuth Capsules, and Pectin Bismuth Granules in the Treatment of Helicobacter Pylori (Hp) First-line Quadruple Regimen: a Multicenter, Randomized, Prospective, Comparative Clinical Trial
- 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)
This study aims to compare efficacy and safety of bismuth-containing quadruple therapy(with rabeprazole amoxicillin clarithromycin)of different kinds of bismuth(Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles)in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bismuth potassium citrate containing quadruple therapy | Drug | — | UNRESOLVED |
| Colloidal pectin bismuth capsules containing quadruple therapy | Drug | — | UNRESOLVED |
| Colloidal pectin bismuth particles A quadruple therapy | Drug | — | UNRESOLVED |
| Colloidal pectin bismuth particles B quadruple therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Bismuth potassium citrate containing quadruple therapy
- description
- Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
- interventionNames
- Drug: Bismuth potassium citrate containing quadruple therapy
- Drug: Colloidal pectin bismuth capsules containing quadruple therapy
- Drug: Colloidal pectin bismuth particles A quadruple therapy
- Drug: Colloidal pectin bismuth particles B quadruple therapy
- type
- ACTIVE_COMPARATOR
- label
- Colloidal pectin bismuth capsules containing quadruple therapy
- description
- Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
- interventionNames
- Drug: Bismuth potassium citrate containing quadruple therapy
- Drug: Colloidal pectin bismuth capsules containing quadruple therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18\~75,both gender. * Patients with upper gastrointestinal symptoms and with documented H.pylori infection. * Patients are willing to receive eradication treatment. * 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: * Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori. * Contraindications to study drugs. * Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. * 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 Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. * Evidence of bleeding or iron efficiency anemia.- Page 3 of 4 \[DRAFT\] - * 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.
References
Publications (1)
- DERIVEDCao Y, Zhang J, Liu Y, Zhang L, Wang L, Wang J, Qi Y, Lv H, Liu J, Huo L, Wei X, Shi Y. The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter, randomized, controlled clinical trial. Medicine (Baltimore). 2021 Dec 17;100(50):e27923. doi: 10.1097/MD.0000000000027923. PMID 34918639