Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication

NCT03897244 | Completed Phase 4 DMC

• 1 other identifier: 201812129MINC
• Study Type: interventional
• Target: 603
• Locations: 1 country
• Sites: 1

Brief Summary

Up to know, three is few large-scale, randomized study prospectively and simultaneously comparing the efficacy, adverse effects and patient compliance of high-dose dual therapy (HDDT) with or without bismuth versus amoxicillin-metronidazole bismuth quadruple therapy (AM-BQT) as first-line regimens for H. pylori eradication. The aims of this study are:

1. 1.to compare the efficacy of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication;
2. 2.to compare the patient adherence and adverse effects of these treatment regimens;
3. 3.to investigate factors that may influence H. pylori eradication by these treatment regimens;
4. 4.to identify the effect of H. pylori eradication on the evolution of ecosystem of microbiota, and inflammatory parameters.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; high dose dual therapy; bismuth high-dose dual therapy; bismuth quadruple therapy

Outcome Measures

Primary Outcomes (1)

• to compare the eradication rate of HDDT with or without bismuth and AM-BQT as first-line regimens for H. pylori eradication.

  The eradication rates (efficacy) of these regimens will be evaluated by the results of C13-urea breath test.

  5.5 years

Secondary Outcomes (1)

• to compare the patient adherence and frequency of adverse effects of these treatment regimens.

  5.5 years

Study Arms (3)

High-dose dual therapy

EXPERIMENTAL

group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)

Drug: High-dose dual therapy (rabeprazole, amoxicillin)

Bismuth High-dose dual therapy

EXPERIMENTAL

group B - Bis-HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days)

Drug: Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate)

Amoxicillin-Metronidazole Bismuth quadruple therapy

ACTIVE COMPARATOR

group C - AM-BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid, for 14 days)

Drug: Amoxicillin-Metronidazole Bismuth quadruple therapy

Interventions

High-dose dual therapy (rabeprazole, amoxicillin) DRUG

High-dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)

Also known as: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin ,Amoxicillin®

High-dose dual therapy

Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate) DRUG

Bismuth-High-dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days)

Also known as: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin ,Amoxicillin®, Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®

Bismuth High-dose dual therapy

Amoxicillin-Metronidazole Bismuth quadruple therapy DRUG

Amoxicillin-Metronidazole Bismuth quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid, for 14 days)

Also known as: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin, Amoxicillin®, Antibiotics, Metronidazole, Flagyl®, Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®

Amoxicillin-Metronidazole Bismuth quadruple therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• pregnant or nursing woman;
• serious concomitant illness and malignant tumor of any kind;
• history of hypersensitivity to test drugs；
• serious bleeding during the course of this ulcer;
• previous gastric surgery;
• receiving bismuth salts, proton pump inhibitors (PPIs), or antibiotics in the previous month.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Proton Pump Inhibitors; Anti-Bacterial Agents; Bismuth; Metronidazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anti-Infective Agents; Therapeutic Uses; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Jyh-Chin Yang, M.D.Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

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: March 27, 2019
• First Posted: April 1, 2019
• Study Start: May 30, 2019
• Primary Completion: February 11, 2025
• Study Completion: February 17, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

TW (1)