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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02466919
Enrollment
114
Registered
2015-06-09
Start date
2014-05-31
Completion date
2016-09-30
Last updated
2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori

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.

Interventions

DRUGMetronidazole

H. pylori eradication therapy

DRUGLevofloxacin

H. pylori eradication therapy

DRUGClarithromycin

H. pylori eradication therapy

DRUGPantoprazole

H. pylori eradication therapy

DRUGAmoxicillin

H. pylori eradication therapy

Sponsors

Ministry of Health and Welfare, Taiwan
CollaboratorOTHER_GOV
Chung-Tai Wu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Helicobacter pylori eradication rate1-4 months after eradication therapyC13-UBT to confirm the H. pylori eradication

Secondary

MeasureTime frameDescription
Chronic inflammatory score1-4 weeks after gastric tissue obtained by upper endoscopyChronic inflammatory score (CIS) can be assessed by the sum of these five pathologic tissues
H. pylori density score1-4 weeks after gastric tissue obtained by upper endoscopyH. pylori density score (HPDS) can be assessed by the sum of these five pathologic tissues
Acute inflammatory score1-4 weeks after gastric tissue obtained by upper endoscopyGastric 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
Spasmolytic polypeptide expressing metaplasia1-4 weeks after gastric tissue obtained by upper endoscopyPresence of spasmolytic polypeptide expressing metaplasia can be evaluated from these five pathologic tissues by special TFF-2 stains
H. pylori resistance panel1-4 weeks after H. pylori culture obtained by upper endoscopyE-test evaluation for antibiotic (amoxicillin, metronidazole, clarithromycin, tetracycline and levofloxacin) resistance
Intestinal metaplasia1-4 weeks after gastric tissue obtained by upper endoscopyPresence of intestinal metaplasia can be evaluated from these five pathologic tissues

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026