Clinical Trials for Helicobacter pylori Infections

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Helicobacter pylori Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 20
• Active, not recruiting: 3
• Completed: 17
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT02373280 — The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

NCT06382493 — Tegoprazan-containing Sequential for H. Pylori

As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

NCT05762991 — Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion

The aim of this study is to evaluate the impact of artificial intelligence (AI) assistance during routine upper endoscopy on gastric cancer-specific mortality. We hypothesize that AI-assisted endoscopic interpretation can further reduce gastric cancer-related mortality through two mechanisms: (1) improved detection of H. pylori infection, facilitating timely eradication therapy and subsequent p…

NCT05332444 — Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

The prevalence of H. pylori antibiotic resistance has reached an alarming level worldwide. Antibiotic stewardship programs should be urgently developed and implemented. However, H. pylori antimicrobial susceptibility testing (AST) is rarely offered, making local resistance patterns not easily available. Guideline-recommended empiric therapies (GR-ET) may no longer reliably achieve high cure rat…

NCT06682533 — Tegoprazan- Versus PPI-based H. Pylori Eradication

In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recom…

NCT07306988 — Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.

The Role of Gut Microbiota in the Mechanism of Helicobacter pylori Eradication-Induced Amelioration of Metabolic Syndrome-Related Parameters

Study Sponsor: Nanjing First Hospital Principal Investigator: Dr. Wanli Liu Department: Gastroenterology Study Duration: February 2025 - August 2025

Key Information for Patients and Families

1. What is this study about? This study aims to understand how…

NCT07516262 — Effect of PPIs on Stool DNA Test for H. Pylori

This prospective, self-controlled clinical study aims to evaluate the impact of proton pump inhibitor (PPI) use on the accuracy of stool DNA testing for Helicobacter pylori (H. pylori) and to assess the applicability of this test in patients receiving PPI therapy. Patients requiring long-term PPI treatment and meeting the inclusion criteria were enrolled. After at least four weeks of PPI therap…

NCT07344506 — CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication

This study, titled CURE-H. Pylori, is a three-arm, parallel-group, open-label, randomized controlled trial designed to evaluate the effectiveness of Dexlansoprazole, Lansoprazole, and Vonoprazan in combination with Levofloxacin and Amoxicillin for Helicobacter pylori eradication. H. pylori infection is a significant health issue worldwide, with an estimated prevalence of 44% globally and around…

NCT06896370 — An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori

This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and non-high-risk subtypes.

NCT06529159 — H. Pylori Eradication With Argon Plasma During Endoscopy

The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broa…

NCT07179159 — Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

NCT04949737 — Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies

Estimating the prevalence of Helicobacter Pylori infection in newly diagnosed stomach cancers in the West-Indies will help to understand the epidemiology of this cancer, which is over-incident in the West Indies compared to France. In addition, the constitution of a biobank (tumor tissues, healthy tissues and serum) will allow to set up in a second time etiological studies to identify other ris…

NCT07358130 — Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy

(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.

NCT07346521 — Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett’s Mucosa During Screening Colonoscopy

The goal of this observational study is to learn how common Helicobacter pylori (H. pylori) infection is in adults without stomach or upper gastrointestinal symptoms who are having a preventive screening colonoscopy.

Endoscopic screening of the stomach is yet not acceptet as a standard screening procedure in Western countries. However, Helicobacter pylori infection is known to increase the ris…

NCT07335406 — Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world’s population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Currently, 14-day high-dose dual therapy containing amoxicillin and bismuth-containing quadruple therapy are the …

NCT07293910 — Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection

Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world’s population, residing in the gastric mucosa and using the mucus layer for protection from the stomach’s high acidity. Its clinical significance is profound: it is classified as a Group 1 carcinogen by the World Health Organization and is a primary cause of chronic gastritis, peptic ulcers, gastr…

NCT07574879 — Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:

Helicobacter pylori (HP) is a well-established pathogen responsible for chronic gastritis and peptic ulcer disease. Its presence has been implicated in the development of gastric malignancies such as adenocarcinoma and mucosa-associated lymphoid tissue lymphoma. Chronic H. pylori infection is associated with systemic inflammatory responses and various extra gastric diseases, including cardiovas…

NCT07576959 — Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication

This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Furthermore, the investigators will investigate the impact of these eradication regimens on the gut microbiota, the development of antibiotic resistance, and changes…

NCT07537634 — Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication

The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.

The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori,…

NCT07439445 — Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication

To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.

Active, Not Recruiting

NCT02164409 — Changes Associated With H. Pylori and Gastric Carcinogenesis

This is a research study for patients who currently have or previously had an H. pylori infection or who have gastric or esophageal cancer and who plan to undergo an endoscopy as part of their care. The purpose of this study is to find out how and why H. pylori infections can cause progression to gastric cancer and if it’s possible for intervention prior to this progression.

NCT07224035 — Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1

H. pylori is an infection of the stomach that can cause chronic gastritis, gastric cancer and peptic ulcer disease. The goal of this study is to screen people for this infection and offer treatment for those who test positive for the infection. By treating those who are positive for H. pylori, there is an opportunity to prevent gastritis, peptic ulcer disease, and even gastric cancer.

NCT07224048 — Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community-AIM 2

H. pylori is an infection of the stomach that can cause chronic gastritis, gastric cancer and peptic ulcer disease. The goal of this study is to screen people for this infection and offer treatment for those who test positive for the infection. By treating those who are positive for H. pylori, there is an opportunity to prevent gastritis, peptic ulcer disease, and even gastric cancer.

Not Yet Recruiting

NCT07405684 — Fecal Molecular Susceptibility-guided Hp First-line Therapy

The goal of this clinical trial is to evaluate the eradication efficacy and health economic benefits of individualized regimens guided by fecal molecular susceptibility testing with 7-day and 14-day courses in the first-line treatment of Helicobacter pylori infection. The main questions it aims to answer are:

1. What is the H. pylori eradication rate of the 7-day versus 14-day individualized r…

NCT07405697 — Fecal Molecular Susceptibility-guided Hp Rescue Therapy

The goal of this clinical trial is to evaluate the eradication efficacy and health economic benefits of individualized regimens guided by fecal molecular susceptibility testing with 7-day and 14-day courses in the rescue treatment of Helicobacter pylori infection. The main questions it aims to answer are:

1. What is the H. pylori eradication rate of the 7-day versus 14-day individualized regim…

NCT07458490 — Predicting Peptic Complications Using H. Pylori Serology and Gastric Ultrasound

This observational study aims to evaluate whether combining a simple blood test (H. pylori serology) with a non-invasive abdominal ultrasound can accurately predict severe complications in patients with peptic ulcer disease (PUD). Peptic ulcer complications, such as stomach bleeding or perforation, are serious and typically require an invasive procedure called an upper endoscopy for diagnosis a…

NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on inv…

NCT07574983 — Levofloxacin-Based Sequential Therapy Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

This randomized controlled trial aims to compare the efficacy and safety of levofloxacin-based sequential therapy versus bismuth-based quadruple therapy for eradication of Helicobacter pylori infection in adult patients. Helicobacter pylori infection remains highly prevalent in developing countries and is associated with gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphom…

NCT07606833 — The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori

This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole versus Esomeprazole-containing Bismuth quadruple therapy for eradication of Helicobacter pylori in China.

NCT07128147 — Detection of Helicopacter Pylori in Patients With Metabolic Associated Fatty Liver Disease

Owing to the correlation between H.pylori and MAFLD, our study aims to search for H.pylori in every patient with MAFLD to aid in the management of MAFLD and improve quality of life for these patients by decreaseing morbidity and mortality.

NCT07624422 — Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection).

Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and second…

Enrolling by Invitation

NCT07010744 — Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection

The Goal of this this clinical trial is to assess and compare the eradication rate of triple and quadruple therapy during treating helicobacter pylori infection among patients presented with dyspepsia. It will also assess the patient reported adverse events among two groups.

H pylori infection will be confirmed by CLO (RUT) test and stool antigen test both.

Standard triple therapy will be bas…

Completed Trials

NCT07408271 — The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change

This clinical controlled study enrolled 73 H. pylori（Helicobacter Pylori ）-infected female participants, stratified into reproductive-age and menopausal cohorts, alongside 10 non-infected controls. Through integrated analysis of routine vaginal discharge parameters and longitudinal amplicon sequencing data of vaginal discharge, investigators analyzed the impact of H. pylori eradication therapy …

NCT06045494 — The Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21

The goal of this non-randomized, open-label, interventional trial is to study the efficacy of treatment for Helicobacter Pylori Infection in Preschooler aged 4-6 by Meiji Yoghurt with LG21. The main question it aims to answer is:

- whether the treatment by Meiji Yoghurt LG21 is effective by stool antigen (HpSA) test

140 qualified participants will be enrolled and non-randomized into 2 groups…

NCT05647278 — Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)

Standard eradication therapies using proton pump inhibitors (PPIs) require double doses to achieve sufficient acid suppression, yet failure rates remain high due to antibiotic resistance. Tegoprazan, a P-CAB agent, inhibits gastric acid more effectively than PPIs. This study hypothesizes that Tegoprazan-based dual therapy can achieve superior or non-inferior eradication rates compared to standa…

NCT06156085 — Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy

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% …

NCT07340593 — Helicobacter Pylori Infection and Gastric Diseases in Lao PDR: First Community-Wide Population-Based Study

This study aims to determine the regional prevalence of Helicobacter pylori infection, bacterial strain differences, and the prevalence of gastric cancer in two provinces of Laos, a multi-ethnic country where these factors may vary by region and ethnicity. The study also evaluates whether H. pylori eradication therapy contributes to disease prevention. Residents aged 18 years or older in Luang …

NCT05444439 — Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy

• Detection of primary antimicrobial susceptibility and resistance of Helicobacter Pylori infection.
• Detection of resistance and virulence genes of Helicobacter Pylori infection.
• Assessment of H pylori carcinogenicity gene.
• Evaluation of outcome and efficacy of antibiotics regimen will be used in our research.
• Evaluation of effect of other factors as diet (fatty and spicy meal), drugs a…

NCT07122284 — Gut Microbiome-Metabolome Profiling in H. Pylori-SIBO Comorbidity

Patients with concurrent Helicobacter pylori infection and small intestinal bacterial overgrowth (SIBO) represent a clinically challenging subgroup, often experiencing refractory gastrointestinal symptoms and diminished treatment responses. Current evidence indicates that individuals infected with H. pylori may related SIBO as a comorbidity; however, the synergistic effects of these conditions …

NCT06340724 — Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail.

NCT06340334 — Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study

To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.

NCT07651202 — H. Pylori Infection and Metabolic Syndrome: A Retrospective Cross-Sectional Study

This retrospective cross-sectional study evaluates the association between Helicobacter pylori infection and metabolic syndrome using health examination data from 5,218 adults at Nanjing First Hospital. Participants are divided into H. pylori-positive and negative groups based on urea breath test results. The primary outcome is metabolic syndrome prevalence (CDS 2020 criteria). Multivariable lo…

NCT07374822 — Real-World Study of Helicobacter Pylori Eradication Success and Its Determinants

This study aims to evaluate the real-world effectiveness of different treatment regimens used to eradicate Helicobacter pylori (H. pylori) infection in routine clinical practice. H. pylori is a common bacterial infection that can lead to chronic gastritis, peptic ulcers, and gastric cancer. Treatment success varies widely in real-world settings due to factors such as antibiotic resistance, pati…

NCT07487142 — Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding"

In the present study, the aim was to report the prevalence of positive H. pylori infection in an unselected population referred for coronary intervention and likely to required DAPT or DPI, also the study assessed impact of H. pylori eradication on occurrence of GI symptoms or bleeding during the follow up period.

NCT06412588 — Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorras…

NCT06561711 — Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare t…

NCT06684860 — RUT vs. Molecular Testing for H. Pylori

The rapid urease test (RUT) is frequently performed for diagnosis of Helicobacter pylori infection in clinical practice. The RUT is a simple and inexpensive method that utilizes a commercial kit containing urea and a pH indicator such as phenol red. In the presence of H. pylori urease, urea is hydrolyzed to ammonia, which raises the pH of the medium, and changes the color of the kit from yellow…

NCT06950489 — Tegoprazan and Amoxicillin Dual Therapy

Dual therapy for Helicobacter pylori refers to a treatment regimen that combines two agents: a potent acid suppressor (such as a proton pump inhibitor [PPI] or a potassium-competitive acid blocker [PCAB]) and the antibiotic amoxicillin. This approach is increasingly recognized as a viable alternative to traditional triple or quadruple therapies, particularly in the context of rising resista…

NCT07455448 — Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study

This study aims to provide an updated analysis of the resistance patterns of H. pylori in the Nanjing region, with a focus on characterizing the current status of phenotypic and genotypic resistance to these six antimicrobial agents. The findings are expected to offer a scientific basis for the rapid diagnosis and personalized treatment of H. pylori infection.

Other (Terminated)

NCT05495854 — New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool

In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological tests (culture and antibiogram and / or PCR) carried out from gastric biopsies. G…