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Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

Primary Purpose

Gastric Cancer, Helicobacter Pylori Infection, Bismuth

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hosipital of Digestive Disease

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2019
Last Updated
April 6, 2021
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT04209933
Brief Title
Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Helicobacter Pylori Infection, Bismuth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bismuth potassium citrate containing quadruple therapy
Arm Type
Active Comparator
Arm Description
Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Arm Title
Colloidal pectin bismuth capsules containing quadruple therapy
Arm Type
Active Comparator
Arm Description
Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Arm Title
Colloidal pectin bismuth particles A quadruple therapy
Arm Type
Active Comparator
Arm Description
Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Arm Title
Colloidal pectin bismuth particles B quadruple therapy
Arm Type
Active Comparator
Arm Description
Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Bismuth potassium citrate containing quadruple therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Colloidal pectin bismuth capsules containing quadruple therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Colloidal pectin bismuth particles A quadruple therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Colloidal pectin bismuth particles B quadruple therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
helicobacter pylori eradication
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.
Time Frame
28 days after treatment]
Secondary Outcome Measure Information:
Title
symptoms effective rates
Description
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
Time Frame
14 days of treatment, and 28 days after treatment
Other Pre-specified Outcome Measures:
Title
adverse events
Description
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.
Time Frame
14 days of treatment, and 28 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xijing Hosipital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34918639
Citation
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.
Results Reference
derived

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Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

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