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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Pantoprazole; Drug: Amoxicillin; Drug: Metronidazole; Drug: Levofloxacin; Drug: Clarithromycin

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Pantoprazole; H. pylori eradication therapy; Other Names: Pantoloc; Drug: Amoxicillin; H. pylori eradication therapy; Drug: Metronidazole; H. pylori eradication therapy; Other Names: Flagyl; Drug: Levofloxacin; H. pylori eradication therapy; Other Names: Cravit
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	Drug: Pantoprazole; H. pylori eradication therapy; Other Names: Pantoloc; Drug: Amoxicillin; H. pylori eradication therapy; Drug: Metronidazole; H. pylori eradication therapy; Other Names: Flagyl; Drug: Clarithromycin; H. pylori eradication therapy; Other Names: Klaricid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chung-Tai Wu
• Collaborators: Ministry of Health and Welfare, Taiwan
• Investigators: Principal Investigator: Yao-Jong Yang, PhD, National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Male non-insulin users with type 2 diabetes mellitus are predisposed to gastric corpus-predominant inflammation after H. pylori infection. J Biomed Sci. 2017 Oct 30;24(1):82. doi: 10.1186/s12929-017-0389-x.
• Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Ten days of levofloxacin-containing concomitant therapy can achieve effective Helicobacter pylori eradication in patients with type 2 diabetes. Ann Med. 2017 Sep;49(6):479-486. doi: 10.1080/07853890.2017.1294761. Epub 2017 Mar 7.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 17, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Helicobacter pylori
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Metronidazole; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Pantoprazole
• Other Study ID Numbers: MOHW103-TDU-B-211-113002 (The Ministry of Health and Welfare, Taiwan)