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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05014334
• Other study ID #: KY20212155-C-1
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 18~70,both gender.

2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;

3. Patients are willing to receive eradication treatment.

4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.

2. Patients with contraindications or allergies to the study drug.

3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.

4. 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).

5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.

6. Pregnant or lactating women.

7. Underwent upper gastrointestinal Surgery.

8. Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.

9. Patients have symptom of dysphagia.

10. Evidence of bleeding or iron efficiency anemia.

11. A history of malignancy.

12. Drug or alcohol abuse history in the past 1 year.

13. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

14. Patients who has psychological problem or poor compliance.

15. Enrolled in other clinical trials in the past 3 months.

16. Refuse to sign informed consent.

Related Conditions & MeSH terms

• Chronic Gastritis
• Gastritis
• Helicobacter Pylori Infection

Intervention

Drug:
• Berberine
berberine 500 mg, twice daily for 14 days
• Vonoprazan
Vonoprazan 20 mg, twice daily for 14 days
• Amoxicillin
amoxicillin 1000mg, twice daily for 14 days.
• Rabeprazole
Rabeprazole 10mg, twice daily for 14 days.
• Bismuth
Bismuth 220mg, twice daily for 14 days.
• Clarithromycin
clarithromy 500mg, twice daily for 14 days.

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days after treatment
Secondary	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	14 days of treatment, and 28 days after treatment
Secondary	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