Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori (Helipro)

March 25, 2019 updated by: Didier Baert, Algemeen Ziekenhuis Maria Middelares

Prospective Analysis of the Eradication Percentage of Helicobacter Pylori, to Evaluate the Effect of Standardized Eradication Schemes and Active Communication With the General Practitioner and Patient.

Patients who test Helicobacter pylori positive, are treated with antibiotics. However, due to a number of factors (such as unknown treatment compliance, no standardized follow-up, ...), a relative low eradication-percentage was reported.

Therefore, the investigators want to measure the anticipated improvement in eradication-percentage due to the standardized treatment schedules (1st line, 2nd line and further) and the optimized communication with the general practitioner and patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Patients who test Helicobacter pylori positive, are treated with antibiotics. However, due to a number of factors (such as unknown treatment compliance, no standardized follow-up, ...), a relative low eradication percentage was reported. Therefore, the investigators want to measure the anticipated improvement in eradication percentage due to the standardized treatment schemes (1st line, 2nd line and further) and the optimized communication with the general practitioner and patients.

If a patient is eligible (Helicobacter pylori positive) :

  1. The standardized eradication scheme in 1st line is:

    sequential therapy being the first 5 days (PPI 2x40mg/d + amoxicilline 2x1g/d), followed by 5 days (PPI 2x40mg/d + clarithromycin 2x500mg/d + flagyl 2x500mg/d)

  2. A standardized letter is sent to the general practitioner, mentioning the eradication scheme, and the need to test for eradication success after 8 weeks. A copy of this letter is being sent to the patient. An information folder about Helicobacter pylori infection with instructions on what is expected from the patient, is sent to the patient.
  3. After 8 weeks, a control helicobacter pylori breath test (An ureum breath test is a type of test performed on air generated from the act of exhalation ; this test is specific to detect Helicobacter pylori) is performed, and a questionnaire is filled in by the patient.
  4. If the ureum breath test is positive, a 2nd line treatment is started = tryplera schedule for 10 days (4x3 co/dag + PPI 2x40mg/d) (1 co tryplera contains 140mg bismuthsubcitrate, 125mg metronidazole, 125mg tetracycline hydrochloride)
  5. A standardized letter is sent to the general practitioner, mentioning the 2nd line eradication scheme, and the need to test for eradication success after 8 weeks. A copy of this letter is being sent to the patient.
  6. After 8 weeks, a control helicobacter pylori breath test is performed, and a questionnaire is filled in by the patient.
  7. If the breath test is positive, a 3rd line treatment is started, based on the results of an antibiogram.
  8. A standardized letter is sent to the general practitioner, mentioning the 3rd line eradication schedule, and the need to test for eradication success after 8 weeks. A copy of this letter is being sent to the patient.
  9. After 8 weeks, a control helicobacter pylori breath test is performed, and a questionnaire is filled in by the patient.

Overall time-frame : a maximum of 100 helicobacter-positive patients will be recruited over a period of 1 year. Included patients are followed up for 30 weeks maximally.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • AZ Maria Middelares

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with a positive test result for Helicobacter pylori (either on a Helicobacter pylori ureum breath test, a biopsy or a faeces test)

Description

Inclusion Criteria:

  • positive test result for Helicobacter pylori (either on a Helicobacter pylori ureum breath test, a biopsy or a faeces test)
  • 18+

Exclusion Criteria:

  • former failure on Helicobacter pylori eradication with antibiotics
  • known allergy for amoxicillin, clarithromycin, flagyl or tryplera

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The presence of Helicobacter pylori is measured using a 13C-ureum breath test (performed minimally 8 wks after the eradication scheme with antibiotics)
Time Frame: Each treatment cycle is about 10 weeks per patient. (10 days antibiotics treatment + 8wks waiting time before Helicobacter pylori breath test). Outcome measurement will be tested at week10, 20 or maximally week30 (depending on number of eradications)
From all included Helicobacter pylori infected patients, a breath test gives a pos/neg result for the presence of Helicobacter pylori. If not successful after a first antibiotics therapy of 10 days, a second-line antibiotics therapy will be initiated, followed by a breath test after minimally 8 weeks. If not successful after a second treatment, a third-line will be started + breath test to test the eradication. Overall, we aim at an eradication percentage of more than 48%.
Each treatment cycle is about 10 weeks per patient. (10 days antibiotics treatment + 8wks waiting time before Helicobacter pylori breath test). Outcome measurement will be tested at week10, 20 or maximally week30 (depending on number of eradications)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Algemeen Ziekenhuis Maria Middelares

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Didier Baert, MD, Algemeen Ziekenhuis Maria Middelares

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Helipro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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