Helicobacter Pylori Infection, Antibiotic Resistant Infection, Antibiotic Resistant Strain
Conditions
Brief summary
The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.
Detailed description
Study design: Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.
Interventions
Proton pump inhibitor
Antibiotic
Antibiotic
DRUGMetronidazole
Antibiotic
DRUGTetracycline 125 MG
Antibiotic
Antibiotic adjuvant
DRUGRifabutin 150 MG
Antibiotic
Antibiotic
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigators performing urea breath test 30 days after the end of the treatment (assessment of the primary outcome: eradication rate) will not be aware of participants' allocation and received therapy. Moreover, two independent investigators will perform RT-PCR on stool samples and gastric biopsy specimens, blinded to the other test results.
Intervention model description
Open-label, multicenter, parallel-arm randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* presence of dyspeptic symptoms, according to Rome IV criteria; * Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology); * naive to Helicobacter pylori treatment; * written informed consent.
Exclusion criteria
* previous Helicobacter pylori treatment; * diagnosis of gastric cancer or other diseases requiring surgery; * contraindications to upper endoscopy; * chronic diarrhea; * known allergy to any drugs used in the intervention and control arm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate | 30 days | Number of participants achieving Helicobacter pylori eradication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 10 days | Any adverse event occurring during the 10-day treatment |
| Participants' compliance | 10 days | Number of assumed tablets divided by the total number of prescribed tablets |
| Treatment withdrawal | 10 days | Withdrawal of any drug included in the prescribed regimen |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy parameters | 30 days | Sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratio, and accuracy of the RT-PCR on fecal samples for the detection of antibiotic resistances |
Countries
Italy
Contacts
Primary ContactMichele Barone, Prof.
Outcome results
None listed