Back to resultsA Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Primary Purpose
Gastric Cancer, Helicobacter Pylori Infection, Bismuth
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
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:
- 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.
- 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 Type
Experimental
Arm Label
Quadruple therapy with colloidal bismuth pectin granules
Arm 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.
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 improvement rates
symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement 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, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
Full Information
NCT ID
NCT04660123
First Posted
December 2, 2020
Last Updated
January 29, 2023
Sponsor
Xijing Hospital of Digestive Diseases
1. Study Identification
Unique Protocol Identification Number
NCT04660123
Brief Title
A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Official Title
A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (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
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.
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: Patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form.
Treatment: Subjects will receive 14 days of eradication treatment. With the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2 antibiotics will be selected on the basis of the physician's experience.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
959 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadruple therapy with colloidal bismuth pectin granules
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Intervention Description
Standard dose of proton pump inhibitor, bismuth , and 2 antibiotics, 14 days course.
Standard doses of proton pump inhibitors are esomeprazole 20mg, rabeprazole 10mg (or 20mg).
Omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg, alprazole 5mg, any one of these.
Bismuth is colloidal bismuth pellets, 150mg, 2 times/d.
Antibiotic Program:
Scheme 1 Amoxicillin 1000 mg, 2 times/d; Clarithromycin 500mg, 2 times per day Scheme 2 Amoxicillin 1000 mg, 2 times/d; Levofloxacin 5001 times/2 times Scheme 3 Amoxicillin 1000 mg, 2 times/d; Furazolidone 100mg, 2 times/d. Scheme 4 Amoxicillin 1000 mg, 2 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 5 Amoxicillin 1000 mg, 2 times/d; Tetracycline 500mg, 3 times/d or 4 times/d Scheme 6 Tetracycline 500mg, 3 times/d or 4 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 7 Tetracycline 500mg, 3 times/d or 4 times/d; Furazolidone 100mg, 2 times/d.
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 improvement rates
Description
symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement 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, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting 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:
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.
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
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A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
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