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Tailored Vs. Empirical Helicobacter Pylori Infection Treatment

NCT ID: NCT06200779

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-12-31

Brief Summary

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Helicobacter pylori (Hp) is a gram-negative bacterium that colonizes human gastric mucosa and is associated with chronic gastritis that can progress to severe complications such as peptic ulcer disease, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma. More than half of the world's population is infected with H. pylori and Portugal is one of the countries with the highest Hp burden. All of infected patients should be treated, however, H. pylori treatment is challenged by the continuously rising antibiotic resistance which has reached alarming levels worldwide. For this reason, it is now well accepted that tailoring treatment of H. pylori infection based on systematic antimicrobial susceptibility testing is useful to avoid the increase of antibiotic resistance.

Our aims are to determine prospectively the efficacy and safety of first-line H. pylori eradication treatment based on resistance profile (determined by molecular methods) vs. empirical bismuth quadruple therapy, to evaluate the accuracy of H. pylori detection by polymerase chain reaction (PCR) (vs. histopathological examination) and to estimate the prevalence of H. pylori infection and H. pylori resistance to clarithromycin and levofloxacin in Portugal.

This prospective study will be the first national study to investigate the benefits of tailored H. pylori eradication treatment. The investigators expect that this project will be able to demonstrate the non-inferiority of susceptibility-guided treatment comparing with empirical therapy, and our results may change H. pylori treatment recommendations by systematically applying antibiotic susceptibility testing before prescribing eradication therapy.

Detailed Description

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A prospective, multicenter, randomized, controlled interventional trial in two arms: intervention group and control group.

Eligible patients will receive oral and written information and will be enrolled after giving written informed consent.

In all patients complete gastroscopy with white light will be performed and endoscopic findings will be recorded. For each patient, gastric body and antral biopsies will be collected. All gastric samples will be tested for H. pylori infection by histopathological examination and PCR. All H. pylori positive samples will be tested for clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) by PCR.

All H. pylori positive patients will be randomized in two groups:

INTERVENTION GROUP: Patients randomized to the Intervention group will receive a prescription for oriented H. pylori eradication treatment according to the following rules: a) clarithromycin-sensitive strain (independently of levofloxacin resistance test result) - PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days; b) clarithromycin-resistant and levofloxacin-sensitive strain - PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days; c) clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that).

CONTROL GROUP: Patients randomized to the Control group will receive a prescription for empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that).

All patients that complete eradication treatment regimen will be evaluated 2 to 4 weeks after performing the eradication control (urea breath test) in a clinical consultation. Eventual adverse effects will be recorded. A negative breath test will define the success of the treatment, while a positive test will define treatment failure. The latter will be managed according to H. pylori infection guidelines.

Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori Antibiotic resistance Eradication treatment Molecular pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group: Patients will receive a prescription for oriented H. pylori eradication treatment according to the following rules: a) clarithromycin-sensitive strain (independently of levofloxacin resistance test result) - PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days; b) clarithromycin-resistant and levofloxacin-sensitive strain - PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days; c) clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy (Pylera®) for 10 days.

Control Group: Patients will receive a prescription for empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) for 10 days.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention group

Patients randomized to the Intervention group will receive a prescription for oriented H. pylori eradication treatment according to the following rules: a) clarithromycin-sensitive strain (independently of levofloxacin resistance test result) - PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days; b) clarithromycin-resistant and levofloxacin-sensitive strain - PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days; c) clarithromycin-resistant and levofloxacin-resistant strain - bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that).

Group Type ACTIVE_COMPARATOR

Clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) PCR test

Intervention Type DIAGNOSTIC_TEST

Described in "Arms" section

PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days

Intervention Type DRUG

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-sensitive strain

PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days

Intervention Type DRUG

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-sensitive strain

Bismuth quadruple therapy (Pylera®) for 10 days

Intervention Type DRUG

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-resistant strain

Control group

Patients randomized to the Control group will receive a prescription for empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®) for 10 days. At least 4 weeks after stopping antibiotics (and at least 2 weeks after stopping PPIs), an eradication control test will be carried out using a respiratory test (urea breath test) or endoscopic biopsies (if clinical indication for that).

Group Type ACTIVE_COMPARATOR

Empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®)

Intervention Type DRUG

Described in "Arms" section

Interventions

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Clarithromycin (mutations in the 23S rRNA gene, A2134G, A2142G and A2142C mutations) and levofloxacin resistance (mutations in the gyrA gene) PCR test

Described in "Arms" section

Intervention Type DIAGNOSTIC_TEST

Empirically H. pylori eradication treatment with bismuth quadruple therapy (Pylera®)

Described in "Arms" section

Intervention Type DRUG

PPI, amoxicillin 1 g and clarithromycin 500 mg, twice daily, for 10 days

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-sensitive strain

Intervention Type DRUG

PPI, amoxicillin 1g and levofloxacin 250 mg, twice daily, for 10 days

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-sensitive strain

Intervention Type DRUG

Bismuth quadruple therapy (Pylera®) for 10 days

Administered to patients randomized to Intervention group and with H. pylori clarithromycin-resistant and levofloxacin-resistant strain

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Individuals older than 18 years old scheduled for upper GI endoscopy with indication for gastric biopsies (clinical or endoscopic findings)

Exclusion Criteria

* 1st phase (clinical): patients who had received antimicrobial therapy 1 month prior to endoscopy; patients who had received proton pump inhibitor (PPI) therapy 2 weeks prior to endoscopy; patients who had ever received H. pylori eradication therapy (despite its efficacy); history of previous gastrectomy; non-Portuguese nationality; pregnant or breastfeeding women; women of childbearing age without effective contraception; suspected or documented allergy to amoxicillin; serious comorbidities (ASA 3 or more); ongoing medication with anticoagulants
* 2nd phase (endoscopic): upper GI tract neoplasia; hemorrhagic gastritis; upper GI tract varices
* 3rd phase (pathological): H. pylori negative patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manuel Coelho da Rocha

OTHER

Sponsor Role lead

Responsible Party

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Manuel Coelho da Rocha

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Unilabs Portugal

Porto, Porto District, Portugal

Site Status

Countries

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Portugal

Facility Contacts

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Manuel Coelho da Rocha, MD

Role: primary

Pedro Pimentel Nunes, MD PhD

Role: backup

Other Identifiers

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Clinical Study Protocol 1

Identifier Type: -

Identifier Source: org_study_id