Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

NCT04558502 | Unknown Phase 4

• 1 other identifier: 2020-584
• Study Type: interventional
• Target: 339
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.

Conditions

Helicobacter Pylori Eradication

Keywords

Helicobacter pylori; Eradication; minocycline; bismuth quadruple regimens

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy

  4-12 weeks after treatment

Secondary Outcomes (1)

• incidence of adverse effects

  3-7 days after treatment

Study Arms (3)

minocycline-based bismuth quadruple regimen for 14 days

EXPERIMENTAL

Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.

Drug: Minocycline hydrochloride capsule; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole

clarithromycin-based bismuth quadruple regimen for 14 days

ACTIVE COMPARATOR

Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.

Drug: Clarithromycin; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole

minocycline-based bismuth quadruple regimen for 10 days

EXPERIMENTAL

Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.

Drug: Minocycline hydrochloride capsule; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole

Interventions

Minocycline hydrochloride capsule DRUG

Antibiotic for H. pylori eradication

Also known as: Meiman

minocycline-based bismuth quadruple regimen for 10 days; minocycline-based bismuth quadruple regimen for 14 days

Clarithromycin DRUG

Antibiotic for H. pylori eradication

Also known as: Klacid

clarithromycin-based bismuth quadruple regimen for 14 days

Amoxicillin DRUG

Antibiotic for H. pylori eradication

clarithromycin-based bismuth quadruple regimen for 14 days; minocycline-based bismuth quadruple regimen for 10 days; minocycline-based bismuth quadruple regimen for 14 days

colloidal bismuth pectin DRUG

Gastric mucosal protective drug with anti-H. pylori effect

clarithromycin-based bismuth quadruple regimen for 14 days; minocycline-based bismuth quadruple regimen for 10 days; minocycline-based bismuth quadruple regimen for 14 days

esomeprazole DRUG

Proton pump inhibitor

clarithromycin-based bismuth quadruple regimen for 14 days; minocycline-based bismuth quadruple regimen for 10 days; minocycline-based bismuth quadruple regimen for 14 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H.pylori-positive outpatients with endoscopically proven chronic gastritis
• H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining
• Treatment-naive patients for eradication of H.pylori infection
• Fully informed and agreed to participate in this study

You may not qualify if:

• Age \<18 years or \>70 years
• Allergy to any of the study drugs
• Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)
• Previous gastric or esophageal surgery
• Patients with malignancy or severe comorbidity
• Pregnancy,lactation or alcohol abuse
• Patients with poor treatment compliance or could not express themselves correctly
• Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

cyclopia sequence

Interventions

Minocycline; Clarithromycin; Amoxicillin; Esomeprazole

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Qin Du, master

  2nd Affiliated Hospital,School of Medicine,Zhejiang University,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Li, master

CONTACT

15906698496; liyan_8786@zju.edu.cn

Yuehua Han, PhD

CONTACT

13858126927; 13858126927@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: January 5, 2022
• Primary Completion: June 5, 2022
• Study Completion: December 5, 2022
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share