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Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Primary Purpose

Helicobacter Pylori Infection, Chronic Gastritis

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Berberine

Vonoprazan

Amoxicillin

Rabeprazole

Bismuth

Clarithromycin

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Berberine, Bismuth, vonoprazan, Helicobacter Pylori

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 3

Arm Type

Experimental

Active Comparator

Arm Label

Berberine-containing triple therapy

Bismuth-containing quadruple therapy

vonoprazan-containing quadruple therapy

Arm Description

vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.

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

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

Outcomes

Primary Outcome Measures

H pylori eradication rates

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

NCT05014334

First Posted

July 12, 2021

Last Updated

January 30, 2023

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT05014334

Brief Title

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Official Title

Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

June 30, 2022 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -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

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

Helicobacter Pylori Infection, Chronic Gastritis

Keywords

Berberine, Bismuth, vonoprazan, Helicobacter Pylori

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Berberine-containing triple therapy

Arm Type

Experimental

Arm Description

vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.

Arm Title

Bismuth-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

vonoprazan-containing quadruple therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Berberine

Intervention Description

berberine 500 mg, twice daily for 14 days

Intervention Type

Drug

Intervention Name(s)

Vonoprazan

Intervention Description

Vonoprazan 20 mg, twice daily for 14 days

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

amoxicillin 1000mg, twice daily for 14 days.

Intervention Type

Drug

Intervention Name(s)

Rabeprazole

Intervention Description

Rabeprazole 10mg, twice daily for 14 days.

Intervention Type

Drug

Intervention Name(s)

Bismuth

Intervention Description

Bismuth 220mg, twice daily for 14 days.

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

Intervention Description

clarithromy 500mg, twice daily for 14 days.

Primary Outcome Measure Information:

Title

H pylori eradication rates

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

Time Frame

14 days of treatment, and 28 days after treatment

Title

adverse events

Description

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

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

Learn more about this trial

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

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