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A Study to Evaluate a New Treatment Option for Helicobacter pylori Infection Compared to First Line Treatment.
EU CTIS ID: 2026-525291-26-00
What this study is testing
The primary objective of the study is to demonstrate the non-inferiority of the fixed combination Test product compared to the standard first-line therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Diagnosed active H. pylori infection established by gastroscopy and CLO test
- No prior treatment for H. pylori infection
- Clear indication for eradication therapy
- Willingness and ability to receive the study medication in the specified dose and frequency throughout the study duration.
- Willingness to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable).
You likely can't join if
- Use of any of the following concomitant medications during participation in the study and within timeframes shorter than the required washout periods: a. Antibiotics: Within the previous 4 weeks. b. PPIs or PCABs: Within the previous 2 weeks. c. Bismuth Compounds: Within the previous 4 weeks.
- Zollinger-Ellison syndrome
- Significant organ dysfunction; severe or unstable cardiopulmonary or endocrine disease
- Gastrointestinal bleeding or related iron-deficiency anemia (IDA); Barrett’s esophagus or high-grade dysplasia; dysphagia; idiopathic thrombocytopenic purpurea (ITP).
- Cockayne Syndrome
- Patients with hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval.
See the full eligibility criteria
Who can join
- Age ≥18 years
- Diagnosed active H. pylori infection established by gastroscopy and CLO test
- No prior treatment for H. pylori infection
- Clear indication for eradication therapy
- Willingness and ability to receive the study medication in the specified dose and frequency throughout the study duration.
- Willingness to provide voluntary written informed consent before any clinical trial related procedure is performed (also refers to legally authorized representatives, where applicable).
What rules you out
- Use of any of the following concomitant medications during participation in the study and within timeframes shorter than the required washout periods: a. Antibiotics: Within the previous 4 weeks. b. PPIs or PCABs: Within the previous 2 weeks. c. Bismuth Compounds: Within the previous 4 weeks.
- Zollinger-Ellison syndrome
- Significant organ dysfunction; severe or unstable cardiopulmonary or endocrine disease
- Gastrointestinal bleeding or related iron-deficiency anemia (IDA); Barrett’s esophagus or high-grade dysplasia; dysphagia; idiopathic thrombocytopenic purpurea (ITP).
- Cockayne Syndrome
- Patients with hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval.
- Documented or suspected atrophic gastritis, which might interfere with the urea breath test (contraindication for Helicobacter Test INFAI).
- Any medical condition or laboratory abnormality during theScreening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's abilityto be included in the study.
- History of substance or alcohol abuse within 1 year prior to the study.
- Hypersensitivity to any of the active substances (metronidazole, bismuth, tetracycline, amoxicillin, clarithromycin, esomeprazole, 13C-urea), to any of the excipients, to other penicillins, macrolide antibiotics, nitroimidazole derivatives, or substituted benzimidazoles. History of a severe immediate hypersensitivity reaction (e.g., anaphylaxis) to another beta-lactam agent (e.g., a cephalosporin, carbapenem, or monobactam).
- History of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes.
- Pregnancy or lactation
- Use of any of the following prohibited medications during participation in the study and within timeframes shorter than the required washout periods: a) Chronic or regular use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or systemic glucocorticoids (steroids) within the past 4 weeks. b) Use of anticoagulants (e.g., warfarin, DOACs) or antiplatelet agents within the past 4 weeks, with the exception of low-dose aspirin (≤100 mg/day).
- Use of any prohibited concomitant medication with known clinically significant or serious interactions with the study treatments, as defined in this protocol (Section 9.1), in the opinion of the Investigator.
- Prior gastric surgery/gastrectomy or other upper gastrointestinal surgery
- Severe comorbidity (e.g., advanced renal, hepatic, or cardiac failure) or malignancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.