Helicobacter Pylori Infection Clinical Trial
— HeliproOfficial 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.
NCT number | NCT02873247 |
Other study ID # | Helipro |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | June 2017 |
Verified date | March 2019 |
Source | Algemeen Ziekenhuis Maria Middelares |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Maria Middelares | Gent |
Lead Sponsor | Collaborator |
---|---|
Algemeen Ziekenhuis Maria Middelares |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The presence of Helicobacter pylori is measured using a 13C-ureum breath test (performed minimally 8 wks after the eradication scheme with antibiotics) | 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) |
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