Helicobacter Pylori ResistanceCRIHEPNCT05019586
Helicobacter Pylori Resistance
An observational study of Helicobacter Pylori Resistance, run by University Hospital of North Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Resistance
- What is being tested?
- levofloxacin, amoxicillin, clarithromycin
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2010to 10 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients referred to a GI- unite with upper GI complains and performing an upper endoscopy -
Who cannot join
- Patients with severe chronic diseases and not willing to participate
About this study
Official title: 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
Read the detailed description
See Nestegard O, et al. PLOS ONE | https://doi.org/10.1371/journal.pone.0238944 September 23, 2020
- Conditions
- Helicobacter Pylori Resistance
- Being tested
- levofloxacin, amoxicillin, clarithromycin
- Keywords
- Gastrointestinal Symptom Rating Scale, Helicobacter pylori resistance, levofloxacin, Sydney score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacin, amoxicillin, clarithromycinDrug
Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: levofloxacin, amoxicillin, clarithromycin | |
| 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 Receives: Drug: levofloxacin, amoxicillin, clarithromycin | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2010-2012
Endoscopy
endoscopic description of mucosa bye endoscopy
Measured: 2010-2012
Histology
Histological characterizations of inflammation (Sydney) of gastric mucosa
Measured: 2010-2012
Immunology
Immunological mucosal characterizations of pro- and antiinflammatory cytokine transcript (PCR)
Measured: 2010-2012
HP microbiology
HP microbiology sensitivity to metronidazol, amoxicillin, clarithromycine, levofloxacin and tetracycline
Measured: 2010-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Apr 2010
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Florholmen, University Hospital of North Norway
- Investigators
- Jon Florholmen, Principal investigator, Department of Gastroenterology, Norwegian Artic University/Universiuty of Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019586
- Sponsor's protocol ID
- University Hosp North Norway
- Acronym
- CRIHEP
- Status last verified
- Aug 2021
- First submitted
- 14 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35442962
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Resistance. A Study of Morbidity, Immunological and Clinical Phenotypes
- ClinicalTrials.gov ID
- NCT05019586
- Acronym / sponsor ID
- CRIHEP / University Hosp North Norway
- Conditions
- Helicobacter Pylori Resistance
- Keywords
- Gastrointestinal Symptom Rating Scale, Helicobacter pylori resistance, levofloxacin, Sydney score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 15 Apr 2010 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pylori resistance | – | Drug: levofloxacin, amoxicillin, clarithromycinPatients 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 | – | Drug: levofloxacin, amoxicillin, clarithromycinPatients 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 |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients referred to a GI- unite with upper GI complains and performing an upper endoscopy -
Key exclusion criteria (1 listed)
- Patients with severe chronic diseases and not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacin, amoxicillin, clarithromycinTriple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days | Drug | Helicobacter pylori resistance, Newly diagnosed Helicobacter pylori |
Primary outcome
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
Endoscopy
Time frame: 2010-2012
endoscopic description of mucosa bye endoscopy
Histology
Time frame: 2010-2012
Histological characterizations of inflammation (Sydney) of gastric mucosa
Immunology
Time frame: 2010-2012
Immunological mucosal characterizations of pro- and antiinflammatory cytokine transcript (PCR)
HP microbiology
Time frame: 2010-2012
HP microbiology sensitivity to metronidazol, amoxicillin, clarithromycine, levofloxacin and tetracycline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 35442962Nestegard 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.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Resistance
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
Recruiting
Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication
Helicobacter Pylori Infection
Recruiting
Tegoprazan-containing Sequential for H. Pylori
Helicobacter Pylori Infection
Not yet recruiting
Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
HELICOBACTER PYLORI INFECTIONS, Rescue Therapy for Helicobacter Pylori
RecruitingPhase 4
Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.
HELICOBACTER PYLORI INFECTIONS, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Florholmen principal investigator
Department of Gastroenterology, Norwegian Artic University/Universiuty of Tromsø, Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Resistance, run by University Hospital of North Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of patients with chronic HP infection resistant to previous conventional triple therapy (time frame: 2010-2012). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.