High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

NCT06561698 | Recruiting Phase 4 DMC

• 1 other identifier: rjhy20240814
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; minocycline; amoxicillin

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (2)

Dual therapy

EXPERIMENTAL

Drug: Vonoprazan; Drug: Amoxicillin

Minocycline bismush quadruple therapy

EXPERIMENTAL

Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Minocycline,Metronidazole

Interventions

Vonoprazan DRUG

Potassium competitive acid blocker

Dual therapy; Minocycline bismush quadruple therapy

Amoxicillin DRUG

Antibiotics for H. pylori eradication

Dual therapy

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline bismush quadruple therapy

Minocycline,Metronidazole DRUG

Antibiotics for H. pylori eradication

Minocycline bismush quadruple therapy

Eligibility Criteria

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

You may qualify if:

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

You may not qualify if:

• Pregnant and lactating women;
• History of gastrointestinal malignancies;
• History of previous subtotal gastrectomy;
• Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
• History of hematological diseases
• People who are allergic to drugs;
• The guardian or patient refused to join the group;
• Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
• No legal capacity or poor self-knowledge
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (10)

Hebi People's Hospital

Hebi, Henan, China

RECRUITING

Jiaozuo People's Hospital

Jiaozuo, Henan, China

RECRUITING

Luoyang central Hospital

Luoyang, Henan, China

RECRUITING

The first people's hospital of ping ding shan

Pingdingshan, Henan, China

RECRUITING

Xuchang central Hospital

Xuchang, Henan, China

RECRUITING

The Second Affiliated Hospital of Henan University of science and technology

Zhengzhou, Henan, China

RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

RECRUITING

Zhengzhou People's Hospital

Zhengzhou, Henan, China

RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, China

RECRUITING

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

cyclopia sequence

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Minocycline; Metronidazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-08

Locations

CN (10)