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

Completed

• Conditions: Helicobacter Pylori Infection

• Registration Number: NCT02873247
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

Brief 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.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Primary Completion: 2016-10
• Study Completion: 2017-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence of Helicobacter pylori is measured using a 13C-ureum breath test (performed minimally 8 wks after the eradication scheme with antibiotics)	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%.

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Gent, Belgium