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Helicobacter Pylori Infection clinical trials

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NCT ID: NCT06250634 Completed - Clinical trials for Helicobacter Pylori Infection

Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.

NCT ID: NCT06228963 Recruiting - Clinical trials for Helicobacter Pylori Infection

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Start date: March 2024
Phase: Phase 2
Study type: Interventional

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

NCT ID: NCT06216639 Enrolling by invitation - Clinical trials for Helicobacter Pylori Infection

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Start date: February 1, 2024
Phase:
Study type: Observational

This prospective non-interventional study is being conducted as part of the EU4Health project Eurohelican. The main goal of this pilot study is to evaluate the feasibility and acceptability of implementing the proposed "test-and-treat" screening program on a population-based sample. Participants will be randomly selected from a younger population registered at the primary level of care and tested for the presence of active infection with Helicobacter pylori (H. pylori). Infected participants will undergo a bismuth-based quadruple treatment with antibiotics and a proton pump inhibitor, and will be controlled for eradication success by taking the urea breath test (UBT). A number of other participant outcomes will be also measured to provide additional pro et contra argumentation for the potential future implementation of a population-based test-and-treat screening program in Slovenia. Research reports will be disseminated and results will be presented to the public and scientific community to foster future developments in gastric cancer prevention.

NCT ID: NCT06200779 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Tailored vs. Empirical Helicobacter Pylori Infection Treatment

Start date: February 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT06190340 Completed - Clinical trials for Helicobacter Pylori Infection

A Phase 1, Multiple Oral Administrations of TNP-2092 Capsules in Asymptomatic Healthy People With Helicobacter Pylori Infection

Start date: November 7, 2016
Phase: Phase 1
Study type: Interventional

This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic profile of TNP-2092 Capsules in asymptomatic healthy subjects with Helicobacter pylori infection, and to explore the preliminary efficacy of TNP-2092 Capsules in eradicating Helicobacter pylori.

NCT ID: NCT06156085 Recruiting - Clinical trials for Helicobacter Pylori Infection

Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy

Start date: November 14, 2023
Phase: Phase 4
Study type: Interventional

Background:Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based dual therapy, on the other hand, is another appealing choice with simplicity, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based dual therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen in Taiwan. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy with high-dose Amoxicillin. Objectives: To compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based dual therapy, through a randomized controlled trial. Methods: Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited. Those who had received H.pylori eradication before, are known to be allergic to any drug used in this trial, are pregnant, or refuse to participate in the trial for any reason will be excluded. We then allocate these patients into two groups randomly - one group receiving vonoprazan-based dual therapy with high-dose amoxicillin (vonoprazan 20 mg + amoxicillin 1000 mg twice daily for fourteen days) and the other receiving extended sequential therapy (lansoprazole 30mg plus amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg, clarithromycin 500mg, and metronidzole 500mg twice daily for an additional 7 days). Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment. Outcome analysis: The study will be designed as a non-inferiority trial. We anticipate that the two regimens will have comparable efficacy. Besides, we'll also design a questionnaire to evaluate the adverse effects, whether they took the drugs in the right way, and patient's satisfaction of the drug regimen. The vonoprazan dual therapy with high-dose amoxicillin will be anticipated to have fewer adverse effects, better compliance, and better satisfaction.

NCT ID: NCT06143124 Recruiting - Clinical trials for Helicobacter Pylori Infection

Bismuth Quadruple Therapy Versus Standard Triple Therapy

BismoHelP
Start date: March 3, 2022
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the standard triple therapy with Bismuth quadruple therapy in children infected with Helicobacter pylori. The main questions to answer are: - the safety - the efficacy of the quadruple protocol with Bismuth subcitrate Participants will be randomised in 7-days eradication therapy group and 14-days eradication control group.

NCT ID: NCT06137573 Completed - Clinical trials for Helicobacter Pylori Infection

Human Mass Balance and Biotransformation Study of [14C]TNP-2198

Start date: July 12, 2022
Phase: Phase 1
Study type: Interventional

The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants

NCT ID: NCT06088316 Recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy of Amoxicillin-Esomeprazole HDDT Compared to Levofloxacin Triple Therapy for H. Pylori Eradication: A RCT

Start date: February 10, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the efficacy of two different therapeutic regimen for the treatment of Helicobacter pylori infected dyspeptic patients. The aim is - 1. To identify the percentage of H. pylori infection among dyspeptic patients 2. To compare the efficacy of amoxicillin-esomeprazole high dose dual therapy with levofloxacin containing triple therapy for the eradication of Helicobacter pylori. Participants will be screened on the basis of two different test (stool antigen test & endoscopy with rapid urease test) to detect H. pylori infection. Who are positive on both tests will be finally enrolled in the study and randomized into two groups . one group will receive amoxicillin & esomeprazole for 14 days in higher dose. The other group will receive amoxicillin, levofloxacin & esomeprazole for 14 days in usual dose. Dyspeptic symptoms will be recorded before & after treatment. Side effects of drugs will also be recorded. Finally 1 month after completion of treatment , H.pylori status will be cheeked by stool antigen test and results will be compared between two groups.

NCT ID: NCT06081712 Completed - Clinical trials for Helicobacter Pylori Infection

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection

Start date: October 20, 2020
Phase: Phase 1
Study type: Interventional

This study was a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy of TNP-2198 capsules.