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Completed

NCT Number: NCT02466919

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

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pantoprazole

Drug

H. pylori eradication therapy

Other names: Pantoloc

Amoxicillin

Drug

H. pylori eradication therapy

Metronidazole

Drug

H. pylori eradication therapy

Other names: Flagyl

Levofloxacin

Drug

H. pylori eradication therapy

Other names: Cravit

Clarithromycin

Drug

H. pylori eradication therapy

Other names: Klaricid

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: 1-4 months after eradication therapy

    C13-UBT to confirm the H. pylori eradication

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Chung-Tai Wu

Other

Collaborators

  • Ministry of Health and Welfare, Taiwan

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2015
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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