Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment

NCT04667299 | Unknown Phase 4

• 1 other identifier: B2020-261
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (PPI+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therapy (PPI+bismuth+ metronidazole+ amoxicillin) for Helicobacter pylori first-line treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication rate of Helicobacter pylori

  Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).

  At least 4 weeks after completion of therapy

Secondary Outcomes (2)

• Eradication rate of Helicobacter pylori metronidazole-resistant strains

  At least 4 weeks after completion of therapy

• Eradication rate of Helicobacter pylori metronidazole-susceptible strains

  At least 4 weeks after completion of therapy

Other Outcomes (2)

• Adherence rate

  At least 1 weeks after completion of therapy

• Frequency of adverse events

  At least 1 weeks after completion of therapy

Study Arms (2)

BMT group

EXPERIMENTAL

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days

Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole

BMQ group

ACTIVE COMPARATOR

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 1 g bid for 14 days

Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Amoxicillin

Interventions

Rabeprazole DRUG

20mg bid

BMQ group; BMT group

Bismuth potassium citrate DRUG

0.6g bid

BMQ group; BMT group

Metronidazole DRUG

0.4g qid

BMQ group; BMT group

Amoxicillin DRUG

1g bid

BMQ group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
• years old on the day of signing the ICF.
• Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
• Have not received Helicobacter pylori eradication treatment before.

You may not qualify if:

• Have received Hp eradication treatment.
• Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
• Subjects or guardians refused to participate in the trial.
• Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
• Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
• Pregnant or lactating women.
• Active peptic ulcer.
• allergic to drugs used in the trial.
• any other circumstances that are not suitable for recruitment.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Rabeprazole; Metronidazole; Amoxicillin

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; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Taotao Liu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Chen, MD

CONTACT

86-17811921405; chenqimd@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: December 8, 2020
• First Posted: December 14, 2020
• Study Start: December 20, 2020
• Primary Completion: November 20, 2021
• Study Completion: December 31, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 5 years after the trial results were published.
• Access Criteria: All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.

Locations

CN (1)