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

  • STATUS
    Not Recruiting
  • participants needed
    100
  • sponsor
    Algemeen Ziekenhuis Maria Middelares
Updated on 22 January 2021
antibiotic therapy
antibiotics

Summary

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.

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.

Details
Condition Helicobacter Pylori Infection
Clinical Study IdentifierNCT02873247
SponsorAlgemeen Ziekenhuis Maria Middelares
Last Modified on22 January 2021

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