Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-31

Brief Summary

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To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure.

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Detailed Description

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Introducing cefuroxime into the remedy treatment of Helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. If the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of Helicobacter pylori.

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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Classic bismuth quadruple treatment group

Group Type ACTIVE_COMPARATOR

Classic bismuth quadruple treatment

Intervention Type DRUG

Classic bismuth quadruple treatment:

Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days.

Cefuroxime containing bismuth quadruple treatment group

Group Type EXPERIMENTAL

Cefuroxime containing bismuth quadruple treatment

Intervention Type DRUG

Cefuroxime containing bismuth quadruple treatment:

Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days.

Interventions

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Cefuroxime containing bismuth quadruple treatment

Cefuroxime containing bismuth quadruple treatment:

Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days.

Intervention Type DRUG

Classic bismuth quadruple treatment

Classic bismuth quadruple treatment:

Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Employees, family members, and patients with positive C13 breath test in our hospital;
* Has received one or more previous Helicobacter pylori eradication therapy (no use of cefuroxime or tetracycline), and the result is still positive by C13 breath test;
* Willing to undergo gastroscopy and HP cultivation and identification;
* Age 18-70, gender unlimited;
* Willing to participate in and cooperate with the study, and willing to sign the informed consent.

Exclusion Criteria

* Drugs that may affect the study results, such as PPI, H2 blockers, bismuth agents, antibiotics, etc. were taken in the 4 weeks before enrollment;
* Patients with gastrointestinal malignancy tumor;
* Patients with gastrinoma;
* After gastric or esophageal surgery;
* Suffers from serious diseases of the heart, lung, kidney, liver, blood, nervous system, endocrine system or mental system;
* Patients with contraindications or previous allergic reactions to the drugs used in this study;
* Pregnant or breastfeeding women;
* Patients with other medical conditions that may increase the treatment side effects;
* Those who cannot give informed consent;
* Has participated in other drug trials within 3 months;
* Not considered suitable for participants by the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No