Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2022-10-30

Brief Summary

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Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori

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Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tetracycline Bismuth Quadruple Therapy

Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline,Metronidazole

Intervention Type DRUG

Antibiotics for H. pylori eradication

rifabutin triple therapy

Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

amoxicillin rifabutin

Intervention Type DRUG

Antibiotics for H. pylori eradication

Interventions

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Esomeprazole

Proton pump inhibitor

Intervention Type DRUG

Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

Tetracycline,Metronidazole

Antibiotics for H. pylori eradication

Intervention Type DRUG

amoxicillin rifabutin

Antibiotics for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria

* Less than 18 years old
* With previous gastric surgery
* Previous history of tuberculosis
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No