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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Helicobacter Pylori Infection; Bismuth
• Intervention / Treatment: 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

Detailed Description

The study will include three phases: screening, treatment and follow-up.Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hosipital of Digestive Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bismuth potassium citrate containing quadruple therapy; 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; 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; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; 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; Drug: Colloidal pectin bismuth particles A quadruple therapy; 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; Drug: Colloidal pectin bismuth particles B quadruple therapy; 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
Active Comparator: Colloidal pectin bismuth capsules containing quadruple therapy; 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; 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; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; 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; Drug: Colloidal pectin bismuth particles A quadruple therapy; 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; Drug: Colloidal pectin bismuth particles B quadruple therapy; 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
Active Comparator: Colloidal pectin bismuth particles A quadruple therapy; 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; 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; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; 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; Drug: Colloidal pectin bismuth particles A quadruple therapy; 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; Drug: Colloidal pectin bismuth particles B quadruple therapy; 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
Active Comparator: Colloidal pectin bismuth particles B quadruple therapy; 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; 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; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; 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; Drug: Colloidal pectin bismuth particles A quadruple therapy; 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; Drug: Colloidal pectin bismuth particles B quadruple therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptoms effective rates	symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe	14 days of treatment, and 28 days after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.	14 days of treatment, and 28 days after treatment

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 21, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Natriuretic Agents; Diuretics; Respiratory System Agents; Expectorants; Antacids; Bismuth; Potassium Citrate
• Other Study ID Numbers: KY20192146-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No