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

Overview

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.

Full Title of Study: “Strategy on the Increment of H. Pylori Eradication Rate and Investigating the Gastric Pathology and Antimicrobial Resistance in Diabetic Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

Interventions

  • Drug: Pantoprazole
    • H. pylori eradication therapy
  • Drug: Amoxicillin
    • H. pylori eradication therapy
  • Drug: Metronidazole
    • H. pylori eradication therapy
  • Drug: Levofloxacin
    • H. pylori eradication therapy
  • Drug: Clarithromycin
    • H. pylori eradication therapy

Arms, Groups and Cohorts

  • Experimental: Levofloxacin-based concomitant
    • Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10
  • Active Comparator: Sequential
    • Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10

Clinical Trial Outcome Measures

Primary Measures

  • Helicobacter pylori eradication rate
    • Time Frame: 1-4 months after eradication therapy
    • C13-UBT to confirm the H. pylori eradication

Secondary Measures

  • Acute inflammatory score
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
  • Intestinal metaplasia
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 1-4 weeks after H. pylori culture obtained by upper endoscopy
    • E-test evaluation for antibiotic (amoxicillin, metronidazole, clarithromycin, tetracycline and levofloxacin) resistance

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chung-Tai Wu
  • Collaborator
    • Ministry of Health and Welfare, Taiwan
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Chung-Tai Wu, National Cheng-Kung University Hospital – National Cheng-Kung University Hospital
  • Overall Official(s)
    • Yao-Jong Yang, PhD, Principal Investigator, National Cheng-Kung University Hospital

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