Tailored Therapy for Helicobacter Pylori Rescue Treatment

NCT ID: NCT03413020

Last Updated: 2018-08-07

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2018-07-31

Brief Summary

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With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tailored Therapy

After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.

Group Type EXPERIMENTAL

esomeprazole

Intervention Type DRUG

proton pump inhibitor

bismuth Potassium Citrate

Intervention Type DRUG

gastric mucosal protective drug with anti-H. pylori effect

amoxicillin

Intervention Type DRUG

antibiotic for H. pylori eradication

clarithromycin

Intervention Type DRUG

antibiotic for H. pylori eradication

metronidazole

Intervention Type DRUG

antibiotic for H. pylori eradication

levofloxacin

Intervention Type DRUG

antibiotic 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

amoxicillin

antibiotic for H. pylori eradication

Intervention Type DRUG

clarithromycin

antibiotic for H. pylori eradication

Intervention Type DRUG

metronidazole

antibiotic for H. pylori eradication

Intervention Type DRUG

levofloxacin

antibiotic for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Previous failures of H. pylori eradication therapy and need rescue therapy
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection

Exclusion Criteria

* Less than 18 years old
* With previous gastric surgery
* 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

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Lu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Yu L, Luo L, Long X, Liang X, Ji Y, Chen Q, Song Y, Li X, Graham DY, Lu H. Susceptibility-guided therapy for Helicobacter pylori infection treatment failures. Therap Adv Gastroenterol. 2019 Sep 9;12:1756284819874922. doi: 10.1177/1756284819874922. eCollection 2019.

Reference Type DERIVED
PMID: 31523279 (View on PubMed)

Other Identifiers

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rjkls2017198

Identifier Type: -

Identifier Source: org_study_id

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