Helicobacter Pylori Resistance (CRIHEP)

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

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

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Resistance
• Intervention / Treatment: Drug: levofloxacin, amoxicillin, clarithromycin

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 185

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. Patients referred to Gastrointestinal (GI) unite in the time periode from 1990 to 2010 and defined as resistant to triple Helicobacter pylori (HP) treatment
2. Patients referred to GI unite in the time periode from 2010 to 2012 due to opper GI complaints. Included were patients a) newly diagnosed HP, b) previously successful triple HP therapy, and c) never HP infected

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Helicobacter pylori resistance; 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; Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days
Newly diagnosed Helicobacter pylori; 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; Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days
Previously eradicated Helicobacter pylori infection; Patients with previously Helicobacter pylori infection included from 2010-2012.
Never Helicobacter pylori infection; Patients with previously Helicobacter pylori infection included from 2010-2012.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Investigators: Principal Investigator: Jon Florholmen, Department of Gastroenterology, Norwegian Artic University/Universiuty of Tromsø, Norway

Publications and helpful links

General Publications

• Nestegard O, Moayeri B, Halvorsen FA, Tonnesen T, Sorbye SW, Paulssen E, Johnsen KM, Goll R, Florholmen JR, Melby KK. Helicobacter pylori resistance to antibiotics before and after treatment: Incidence of eradication failure. PLoS One. 2022 Apr 20;17(4):e0265322. doi: 10.1371/journal.pone.0265322. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2010
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Gastrointestinal Symptom Rating Scale, Helicobacter pylori resistance, levofloxacin, Sydney score
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin
• Other Study ID Numbers: University Hosp North Norway

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No