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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466919
• Other study ID #: MOHW103-TDU-B-211-113002
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2015
• Last updated: September 1, 2016
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chung-Tai Wu	Ministry of Health and Welfare, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	C13-UBT to confirm the H. pylori eradication	1-4 months after eradication therapy	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Intestinal metaplasia	Presence of intestinal metaplasia can be evaluated from these five pathologic tissues	1-4 weeks after gastric tissue obtained by upper endoscopy	No
Secondary	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	No
Secondary	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	No