Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

NCT04209933 | Completed Phase 4

• 1 other identifier: KY20192146-C-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer; Helicobacter Pylori Infection; Bismuth

Outcome Measures

Primary Outcomes (1)

• helicobacter pylori eradication

  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.

  28 days after treatment]

Secondary Outcomes (1)

• symptoms effective rates

  14 days of treatment, and 28 days after treatment

Other Outcomes (1)

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (4)

Bismuth potassium citrate containing quadruple therapy

ACTIVE COMPARATOR

Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

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

Colloidal pectin bismuth capsules containing quadruple therapy

ACTIVE COMPARATOR

Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

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

Colloidal pectin bismuth particles A quadruple therapy

ACTIVE COMPARATOR

Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

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

Colloidal pectin bismuth particles B quadruple therapy

ACTIVE COMPARATOR

Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

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

Interventions

Bismuth potassium citrate containing quadruple therapy DRUG

Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Bismuth potassium citrate containing quadruple therapy; Colloidal pectin bismuth capsules containing quadruple therapy; Colloidal pectin bismuth particles A quadruple therapy; Colloidal pectin bismuth particles B quadruple therapy

Colloidal pectin bismuth capsules containing quadruple therapy DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Bismuth potassium citrate containing quadruple therapy; Colloidal pectin bismuth capsules containing quadruple therapy; Colloidal pectin bismuth particles A quadruple therapy; Colloidal pectin bismuth particles B quadruple therapy

Colloidal pectin bismuth particles A quadruple therapy DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Bismuth potassium citrate containing quadruple therapy; Colloidal pectin bismuth capsules containing quadruple therapy; Colloidal pectin bismuth particles A quadruple therapy; Colloidal pectin bismuth particles B quadruple therapy

Colloidal pectin bismuth particles B quadruple therapy DRUG

Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Bismuth potassium citrate containing quadruple therapy; Colloidal pectin bismuth capsules containing quadruple therapy; Colloidal pectin bismuth particles A quadruple therapy; Colloidal pectin bismuth particles B quadruple therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Cao 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 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 24, 2019
• Study Start: May 25, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 30, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)