Ignite Creation Date:
2025-12-18 @ 9:30 AM
Ignite Modification Date:
2025-12-18 @ 9:30 AM
Study NCT ID:
NCT02873247
Status:
None
Last Update Posted:
2019-03-26 00:00:00
First Post:
2015-09-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
Sponsor:
None
Organization:
Study Overview
Official Title:
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.
Status:
None
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Helipro
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 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: