PPI-amoxicillin for H. Pylori Treatment

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05014685

Collaborator

(none)

732

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

44.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized controlled clinical trial will identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy 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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Rabeprazole Drug: Bismuth potassium citrate Drug: Metronidazole Drug: Amoxicillin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

732 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Proton Pump Inhibitor and Amoxicillin Combined Bismuth or Metronidazole for Helicobacter Pylori First-line Treatment: A Randomized Controlled Trial

Actual Study Start Date :

Aug 20, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RA group	Drug: Rabeprazole 20mg bid Drug: Amoxicillin 1g tid
Experimental: RAM group	Drug: Rabeprazole 20mg bid Drug: Metronidazole 0.4g tid Drug: Amoxicillin 1g tid
Experimental: RAB group	Drug: Rabeprazole 20mg bid Drug: Bismuth potassium citrate 0.6g bid Drug: Amoxicillin 1g tid
Active Comparator: RABM group	Drug: Rabeprazole 20mg bid Drug: Bismuth potassium citrate 0.6g bid Drug: Metronidazole 0.4g tid Drug: Amoxicillin 1g tid

Outcome Measures

Primary Outcome Measures

Eradication rate of Helicobacter pylori [At least 4 weeks after completion of therapy]
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).

Secondary Outcome Measures

Eradication rate of Helicobacter pylori resistant strains [At least 4 weeks after completion of therapy]
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Eradication rate of Helicobacter pylori susceptible strains [At least 4 weeks after completion of therapy]
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.

Other Outcome Measures

Adherence rate [At least 1 weeks after completion of therapy]
Adherence was defined as poor when subjects took less than 80% of the total medication.
Frequency of adverse events [At least 1 weeks after completion of therapy]
Any possible adverse events during the 14-day treatment period were recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
18-75 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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Principal Investigator: Taotao Liu, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05014685

Other Study ID Numbers:

B2021-3761

First Posted:

Aug 20, 2021

Last Update Posted:

Aug 23, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2021