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

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Metronidazole; Drug: Clarithromycin; Drug: Levofloxacin

• Registration Number: NCT02466919
• Lead Sponsor: Chung-Tai Wu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-05-17
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Diabetic patients with Helicobacter pylori infection

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential	Amoxicillin	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10
Levofloxacin-based concomitant	Pantoprazole	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10
Sequential	Metronidazole	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10
Sequential	Clarithromycin	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10
Levofloxacin-based concomitant	Amoxicillin	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10
Levofloxacin-based concomitant	Metronidazole	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10
Levofloxacin-based concomitant	Levofloxacin	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10
Sequential	Pantoprazole	Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	1-4 months after eradication therapy	C13-UBT to confirm the H. pylori eradication

Secondary Outcome Measures

Name	Time	Method
Intestinal metaplasia	1-4 weeks after gastric tissue obtained by upper endoscopy	Presence of intestinal metaplasia can be evaluated from these five pathologic tissues
Spasmolytic polypeptide expressing metaplasia	1-4 weeks after gastric tissue obtained by upper endoscopy	Presence of spasmolytic polypeptide expressing metaplasia can be evaluated from these five pathologic tissues by special TFF-2 stains
H. pylori resistance panel	1-4 weeks after H. pylori culture obtained by upper endoscopy	E-test evaluation for antibiotic (amoxicillin, metronidazole, clarithromycin, tetracycline and levofloxacin) resistance
Acute inflammatory score	1-4 weeks after gastric tissue obtained by upper endoscopy	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
Chronic inflammatory score	1-4 weeks after gastric tissue obtained by upper endoscopy	Chronic inflammatory score (CIS) can be assessed by the sum of these five pathologic tissues
H. pylori density score	1-4 weeks after gastric tissue obtained by upper endoscopy	H. pylori density score (HPDS) can be assessed by the sum of these five pathologic tissues