Rescue Therapy for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

Official Title
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Rescue Therapy for Helicobacter Pylori Eradication: A Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Bismuth Potassium Citrate
* Drug: Tetracycline,Metronidazole
* Drug: Minocycline,Metronidazole


Participation Criteria
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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 failure Exclusion Criteria: subjects naive to H. pylori treatment, under 18 or over 80 years old history of gastrectomy pregnant or lactating women severe systemic diseases or malignancy administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks contraindications to the study drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracycline Bismuth Quadruple Therapy<br>Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Tetracycline,Metronidazole<br>* Antibiotics for H. pylori eradication<br>|
| Experimental: Minocycline Bismuth Quadruple Therapy<br>Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Minocycline,Metronidazole<br>* Antibiotics for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects | The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as mild (transient and well tolerated), moderate (causing discomfort and partially interfering with daily activities), or severe (causing considerable interference with daily activities) | Within 7 days after completion of therapy | 
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within 7 days after completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, rescue therapy, minocycline, tetracycline