Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Study Overview
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Brief Summary
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The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.

Official Title
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Strategy on the Increment of H. Pylori Eradication Rate and Investigating the Gastric Pathology and Antimicrobial Resistance in Diabetic Patients

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: Amoxicillin
* Drug: Metronidazole
* Drug: Levofloxacin
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients with Helicobacter pylori infection Exclusion Criteria: Pregnancy or physically poor performance status Patients with contraindication for upper endoscopy Severe coagulopathy for endoscopic biopsy Chronic kidney disease (eGFR < 50) or end stage renal disease Known allergy to interventional drugs Previous eradication failure

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Levofloxacin-based concomitant<br>Pantoprazole 40 mg BID day1 day10 Amoxicillin 1000 mg BID day1 day10 Metronidazole 500 mg BID day1 day10 Levofloxacin 500 mg QD day1 day10 | Drug: Pantoprazole<br>* H. pylori eradication therapy<br>* Other names: Pantoloc;Drug: Amoxicillin<br>* H. pylori eradication therapy<br>Drug: Metronidazole<br>* H. pylori eradication therapy<br>* Other names: Flagyl;Drug: Levofloxacin<br>* H. pylori eradication therapy<br>* Other names: Cravit;|
| Active Comparator: Sequential<br>Pantoprazole 40 mg BID day1 day10 Amoxicillin 1000 mg BID day1 day5 Metronidazole 500 mg BID day6 day10 Clarithromycin 500 mg BID day6 day10 | Drug: Pantoprazole<br>* H. pylori eradication therapy<br>* Other names: Pantoloc;Drug: Amoxicillin<br>* H. pylori eradication therapy<br>Drug: Metronidazole<br>* H. pylori eradication therapy<br>* Other names: Flagyl;Drug: Clarithromycin<br>* H. pylori eradication therapy<br>* Other names: Klaricid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | C13-UBT to confirm the H. pylori eradication | 1-4 months after eradication therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute inflammatory score | Gastric tissue obtained from antrum (2 pieces), body (2 pieces) and cardia (1 piece) were scoring by modified Sydney system and specific staining. Acute inflammatory score (AIS) can be assessed by the sum of these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy | 
| Chronic inflammatory score | Chronic inflammatory score (CIS) can be assessed by the sum of these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy | 
| H. pylori density score | H. pylori density score (HPDS) can be assessed by the sum of these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy | 
| Intestinal metaplasia | Presence of intestinal metaplasia can be evaluated from these five pathologic tissues | 1-4 weeks after gastric tissue obtained by upper endoscopy | 
| Spasmolytic polypeptide expressing metaplasia | Presence of spasmolytic polypeptide expressing metaplasia can be evaluated from these five pathologic tissues by special TFF-2 stains | 1-4 weeks after gastric tissue obtained by upper endoscopy | 
| H. pylori resistance panel | E-test evaluation for antibiotic (amoxicillin, metronidazole, clarithromycin, tetracycline and levofloxacin) resistance | 1-4 weeks after H. pylori culture obtained by upper endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori