Helicobacter Pylori Resistance

Completed

• Conditions: Helicobacter Pylori Resistance
• Interventions: Drug: levofloxacin, amoxicillin, clarithromycin

• Registration Number: NCT05019586
• Lead Sponsor: University Hospital of North Norway

Brief Summary

The main goal of the study was to characterize the morbidity, immunological, microbiolical and clinical phenotypes of patients with treated- resistance to Helicobacter pylori (HP) infection, and the effect of triple therapy including the levofloxacin. Control groups were newly diagnosed, previously infected and never infected HP patients

Detailed Description

See Nestegard O, et al. PLOS ONE \| https://doi.org/10.1371/journal.pone.0238944 September 23, 2020

Study Timeline

• Study Start: 2010-04-15
• Primary Completion: 2020-07-10
• Study Completion: 2020-07-10
• Status Verified: 2021-08
• Study First Submitted: 2021-08-14
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Patients referred to a GI- unite with upper GI complains and performing an upper endoscopy -

Exclusion Criteria

Patients with severe chronic diseases and not willing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Helicobacter pylori resistance	levofloxacin, amoxicillin, clarithromycin	Patients with treatment resistance to Helicobacter pylori treatment registered at GI-unites from 1990-2012 and included from 2010 to 2012. These patients were treated with a triple therapy of levofloxacin, amoxicillin and proton inhibitor for 10 days
Newly diagnosed Helicobacter pylori	levofloxacin, amoxicillin, clarithromycin	Patients with newly diagnosed Helicobacter pylori infection from 2010-2012.These patients were treated with a triple therapy of clarithromycin, amoxicillin and proton inhibitor for 10 days

Primary Outcome Measures

Name	Time	Method
Endoscopy	2010-2012	endoscopic description of mucosa bye endoscopy
Characterization of patients with chronic HP infection resistant to previous conventional triple therapy	2010-2012	Clinical data including endoscopy, histology, microbiological data including resistance measurements, immunological data (mucosal tranacrips), effect of triple therapy
Histology	2010-2012	Histological characterizations of inflammation (Sydney) of gastric mucosa
Immunology	2010-2012	Immunological mucosal characterizations of pro- and antiinflammatory cytokine transcript (PCR)
HP microbiology	2010-2012	HP microbiology sensitivity to metronidazol, amoxicillin, clarithromycine, levofloxacin and tetracycline