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OpenTrials
Completed

NCT Number: NCT05019586

Helicobacter Pylori Resistance

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

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

levofloxacin, amoxicillin, clarithromycin

Drug

Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days

Primary outcomes

  1. Characterization of patients with chronic HP infection resistant to previous conventional triple therapy

    Time frame: 2010-2012

    Clinical data including endoscopy, histology, microbiological data including resistance measurements, immunological data (mucosal tranacrips), effect of triple therapy

  2. Endoscopy

    Time frame: 2010-2012

    endoscopic description of mucosa bye endoscopy

  3. Histology

    Time frame: 2010-2012

    Histological characterizations of inflammation (Sydney) of gastric mucosa

  4. Immunology

    Time frame: 2010-2012

    Immunological mucosal characterizations of pro- and antiinflammatory cytokine transcript (PCR)

  5. HP microbiology

    Time frame: 2010-2012

    HP microbiology sensitivity to metronidazol, amoxicillin, clarithromycine, levofloxacin and tetracycline

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Acronym: CRIHEP

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2021
Registry last updated
Aug 25, 2021

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.