Helicobacter Pylori Resistance

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

Official Title
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Helicobacter Pylori Resistance. A Study of Morbidity, Immunological and Clinical Phenotypes

Conditions
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Helicobacter Pylori Resistance

Intervention / Treatment
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* Drug: levofloxacin, amoxicillin, clarithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Helicobacter pylori resistance<br>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 | Drug: levofloxacin, amoxicillin, clarithromycin<br>* Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days<br>|
| Newly diagnosed Helicobacter pylori<br>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 | Drug: levofloxacin, amoxicillin, clarithromycin<br>* Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days<br>|
| Previously eradicated Helicobacter pylori infection<br>Patients with previously Helicobacter pylori infection included from 2010-2012. | |
| Never Helicobacter pylori infection<br>Patients with previously Helicobacter pylori infection included from 2010-2012. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Symptom Rating Scale, Helicobacter pylori resistance, levofloxacin, Sydney score