Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

NCT06603688 | Unknown Phase 4

• 1 other identifier: KY20232384-C-1
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication. The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.

Conditions

Helicobacter Pylori Infection; Chronic Gastritis

Keywords

Berberine; Bismuth; Helicobacter Pylori; Minocycline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• symptoms effective rate

  14 days of treatment, and 28 days after treatment

Other Outcomes (1)

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (2)

experimental group：Minocycline+Berberine quadruple therapy

EXPERIMENTAL

40mg of esomeprazole, 220mg of colloidal bismuth tartrate, 500mg of berberine hydrochloride, and 100mg of minocycline, taken orally twice daily for 14 days.

Drug: esomeprazole; Drug: Bismuth; Drug: Berberine; Drug: Minocycline

control group：Amoxicillin+clarithromycin quadruple

ACTIVE COMPARATOR

40mg of esomeprazole, 220mg of bismuth tartrate colloid, 500mg of clarithromycin, and 1000mg of amoxicillin, taken orally twice a day for 14 days.

Drug: esomeprazole; Drug: Bismuth; Drug: Amoxicillin; Drug: clarithromycin

Interventions

esomeprazole DRUG

Esomeprazole 40mg, twice daily for 14 days.

control group：Amoxicillin+clarithromycin quadruple; experimental group：Minocycline+Berberine quadruple therapy

Bismuth DRUG

Bismuth 220mg, twice daily for 14 days.

control group：Amoxicillin+clarithromycin quadruple; experimental group：Minocycline+Berberine quadruple therapy

Amoxicillin DRUG

Amoxicillin 1000mg, twice daily for 14 days.

control group：Amoxicillin+clarithromycin quadruple

clarithromycin DRUG

clarithromycin 500mg, twice daily for 14 days.

control group：Amoxicillin+clarithromycin quadruple

Berberine DRUG

Berberine 500 mg, twice daily for 14 days

experimental group：Minocycline+Berberine quadruple therapy

Minocycline DRUG

Minocycline 100 mg, twice daily for 14 days

experimental group：Minocycline+Berberine quadruple therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

cyclopia sequence

Interventions

Esomeprazole; Bismuth; Amoxicillin; Clarithromycin; Berberine; Minocycline

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

yongquan shi, Ph. D

CONTACT

86-29-84771515; shiyquan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: November 20, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)