Back to resultsHelicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
Primary Purpose
Dyspepsia, Chronic Gastritis, Gastric Cancer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Berberine
Amoxicillin
Rabeprazole
Amoxicillin
Clarithromycin
Rabeprazole
Bismuth
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Helicobacter pylori, Berberine
Eligibility Criteria
Inclusion Criteria:
- Age between 18~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion Criteria:
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- 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 moderate to severe dysplasia or high degree of intraepithelial neoplasia.
- Patients 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 2
Arm Type
Experimental
Active Comparator
Arm Label
berberine , amoxicillin and rabeprazole triple therapy
Bismuth-containing Quadruple Therapy
Arm Description
Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days.
amoxicillin 1000 mg，clarithromy 500mg，rabeprazole 10 mg, and Bismuth 220mg 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 urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.
Secondary Outcome Measures
symptoms effective rate
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 x 100%.
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 3 presenting most severe
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.
Full Information
NCT ID
NCT04697186
First Posted
January 4, 2021
Last Updated
January 29, 2023
Sponsor
Xijing Hospital of Digestive Diseases
1. Study Identification
Unique Protocol Identification Number
NCT04697186
Brief Title
Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
Official Title
Efficacy and Safety of Berberine Hydrochloride, Amoxicillin and Rabeprazole Triple Therapy in the First Eradication of Helicobacter Pylori
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 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
This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Detailed Description
Detailed Description:
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen 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 13 and 17.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Chronic Gastritis, Gastric Cancer, Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Berberine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Actual)
8. Arms, Groups, and Interventions
Arm Title
berberine , amoxicillin and rabeprazole triple therapy
Arm Type
Experimental
Arm Description
Berberine 300mg three time daily for 14days, amoxicillin 1000 mg and rabeprazole 10 mg by mouth, twice daily for 14 days.
Arm Title
Bismuth-containing Quadruple Therapy
Arm Type
Active Comparator
Arm Description
amoxicillin 1000 mg，clarithromy 500mg，rabeprazole 10 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Berberine
Intervention Description
berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxy
Intervention Description
berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Other Intervention Name(s)
Pariet
Intervention Description
berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxy
Intervention Description
Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
Krashen
Intervention Description
Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Other Intervention Name(s)
Pariet
Intervention Description
Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
Intervention Type
Drug
Intervention Name(s)
Bismuth
Intervention Description
Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication
Description
The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.
Time Frame
28 days after treatment
Secondary Outcome Measure Information:
Title
symptoms effective rate
Description
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 x 100%.
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 3 presenting most severe
Time Frame
14 days of treatment, and 28 days after treatment
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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18~70,both gender.
Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
Patients are willing to receive eradication treatment.
Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion Criteria:
Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
Patients with contraindications or allergies to the study drug.
Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
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 moderate to severe dysplasia or high degree of intraepithelial neoplasia.
Patients 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
Plan to Share IPD
No
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Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy
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