Clinical Research Directory

Bacillus Probiotics With Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Helicobacter pylori (H. pylori) is a very common gastrointestinal disease that colonises the human gastric mucosa and is a primary risk factor for chronic gastritis, peptic ulcer disease, and gastric cancer. The standard first-line treatment for H. pylori eradication is bismuth-containing quadruple therapy. While effective, this aggressive, multi-antibiotic regimen frequently induces significant gastrointestinal adverse effects and severe disruption of the normal gut microbiota (dysbiosis). These side effects often lead to poor patient compliance, which in turn contributes to treatment failure and the increasing global challenge of antibiotic resistance. Emerging clinical evidence strongly supports the use of probiotics as an adjuvant therapy to alleviate antibiotic-associated side effects and significantly aid in restoring intestinal balance. Spore-forming Bacillus species, specifically Bacillus clausii, Bacillus subtilis, and Bacillus coagulans, are particularly advantageous due to their natural resistance to acidic gastric conditions and concurrent antibiotic administration, allowing them to remain viable and active during the intensive eradication therapy. This clinical trial is designed as a randomised, double-blind, placebo-controlled study to evaluate the clinical efficacy, adverse effects, and treatment adherence of a standard four-drug bismuth-containing regimen for the treatment of H. pylori infection when combined with single-strain and multi-strain Bacillus probiotics. The trial is conducted in the Gastroenterology Department of Tam Anh Hospital. 336 participants diagnosed with H. pylori infection and prescribed the standard 14-day bismuth-containing quadruple therapy are randomly divided and allocated to receive either a single-strain probiotic (LiveSpo Clausy), a multi-strain probiotic (LiveSpo DIA 30), or an identical placebo. Over 8 weeks of follow-up, participants will be assessed at predefined time points for antibiotic-associated adverse events, gastrointestinal symptoms, stool form, treatment adherence, and Helicobacter pylori eradication status. Stool samples will be collected before and after treatment to evaluate faecal IgA levels, the presence of Bacillus strains, and changes in gut microbiota using real-time PCR, ELISA, and 16S rRNA sequencing.

A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.

Efficacy and Safety of Black Seed Oil With Vonoprazan Based Triple Therapy in Treatment of Helicobacter Pylori

The aim of this study is to: • Evaluation of efficacy and safety of adding black seed oil with vonoprazan triple therapy ( vonoprazan ,clarithromycin and amoxicillin ) in eradication of Helicobacter pylori infection and this will be done through evaluation of: A. Efficacy by: 1. determination of successful eradication,which will be considered to be achieved on the basis of a negative stool antigen test four weeks after the end of treatment using Stool Ag test 2. The effect of N. Sativa on: I. Oxidative stress by measuring MDA II. Inflammation by measuring IL1B as inflammatory markers B. Safety will be done through: Monitoring of expected treatment related adverse effects (black seed oil and vonoprazan triple therapy ) will be done through the whole study period. C. Symptoms evaluation using the Gastrointestinal symptom rating scale D. Assessment of patient's quality of life using SF36 questionnaire

NLR and PLR in H. Pylori-Associated Gastritis

This cross-sectional study aims to evaluate the role of neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) as inflammatory markers in patients with Helicobacter pylori-associated gastritis at Assiut University Hospitals.

HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in Patients With Acute Myocardial Infarction

Background: Potent antithrombotic therapy has improved prognosis for patients with acute myocardial infarction (MI) significantly, however, at a price of increased bleeding risk. Helicobacter pylori (H. pylori) infection commonly causes upper gastrointestinal bleeding (UGIB). If systematic screening for H. pylori significantly reduces the risk of UGIB and improves outcomes is unknown. Study design: A cluster randomized, cross-over, registry-based clinical trial using nationwide Swedish registries for study population definition and data collection. Population: Patients discharged alive after hospitalization for acute type 1 MI at up to 40 hospitals across Sweden. Regional PCI networks comprise 18 clusters. Clusters will be randomized to routine H. pylori screening or no screening for 1 year after which cross-over to the opposite strategy occurs for 1 year. The study ends after one additional year of registry-based follow-up, one year after the end of the second period. Intervention: All MI patients will routinely be offered screening for H. pylori by urea breath test. Controls: Standard clinical practice. Data will be collected from SWEDEHEART and national registries. For patients testing H. pylori positive, eradication therapy will be prescribed at the caring physician's discretion. The individual implementation of H. pylori screening, test result and eradication therapy prescription will be recorded in SWEDEHEART. All follow-up data is collected from SWEDEHEART and national registries. Outcome: Primary outcome is UGIB defined as hospitalization or an outpatient visit in specialized care with ICD codes corresponding to UGIB. The secondary endpoints (in hierarchical) order: 1. Net Adverse Clinical Events (NACE): All-cause death, UGIB, hospitalization for MI, or hospitalization for ischemic stroke. 2. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE): CV death, hospitalization for MI, or hospitalization for ischemic stroke. 3. All-cause death. 4. CV death. 5. Hospitalization for MI. 6. Hospitalization for stroke. 7. Hospitalization for HF. 8. UGIB requiring blood transfusion.

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 therapy, a stool DNA test was performed, along with collection of gastric mucosal samples via gastroscopy for tissue PCR, histology, and rapid urease testing, as well as H. pylori antibody detection. Subsequently, PPI treatment was discontinued for four weeks, after which a 13C-urea breath test and a repeat stool DNA test were conducted. By comparing the sensitivity, specificity, and consistency of stool DNA testing before and after PPI discontinuation, this study aims to characterize the interference of PPIs with the test results, thereby providing evidence to support improvements in H. pylori diagnostic methods.

VA Dual Sequential Therapy

Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics. Based on this, the investigators propose a modified sequential therapy, where the first phase uses vonoprazan combined with amoxicillin, and the second phase increases the amoxicillin dosage, forming a high-dose amoxicillin regimen. This new treatment strategy combines the staged nature of sequential therapy with the advantages of high-dose dual therapy, gradually increasing the drug dosage to help patients adapt and reduce side effects (such as nausea, vomiting, and diarrhea), thereby improving patient tolerance. The primary aim of this study is to compare the vonoprazan combined with high-dose amoxicillin sequential therapy with standard dual therapy (14-day regimen) in terms of Hp eradication rates, efficacy, side effect incidence, and patient compliance, to evaluate its improved effectiveness. Additionally, the study will explore the impact of a shortened treatment duration on the modified dual sequential therapy's efficacy for Hp infection. Eligible participants in this study will be randomly assigned to one of the following three treatment groups based on a pre-generated randomization sequence: Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VADT-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 1: Vonoprazan combined with amoxicillin dual sequential therapy for 14 days (VAST-14): Days 1 to 7: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 8 to 14: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 2: Vonoprazan combined with amoxicillin dual sequential therapy for 10 days (VAST-10): Days 1 to 5: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 6 to 10: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.

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. Guided therapy is more effective, cheaper, and better tolerated than empiric therapy (it includes fewer antibiotics). But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy, the difficulty of culture and the non-reimbursement of the PCR. A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients (Pichon et al J Clin Microbiol 2020). These characteristics allow this test to be used in primary care but has to be evaluated.

White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Hp Infection

By comparing the characteristics of Helicobacter pylori (Hp) infection under magnifying endoscopy and white light endoscopy, and making judgments of Hp infection status, the advantages and disadvantages of the two endoscopic examination methods are summarized to improve the accuracy of subsequent endoscopic Hp infection status judgments.

Metronidazole- Versus Tinidazole-Based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

This randomized, open-label clinical trial will compare two bismuth-containing quadruple therapies for the first-line treatment of Helicobacter pylori infection. Adults aged 18 years or older with confirmed H. pylori infection who have not previously received eradication treatment will be randomly assigned in a 1:1 ratio to receive either a metronidazole-based regimen or a tinidazole-based regimen for 14 days. Both regimens will also include esomeprazole, tetracycline, and bismuth subcitrate. The main purpose of the study is to determine whether the tinidazole-based regimen is not inferior to the metronidazole-based regimen in achieving successful H. pylori eradication. Eradication will be assessed after treatment using a carbon-13 urea breath test or an endoscopic urease test. The study will also compare adverse effects and treatment tolerability between the two groups. The results may help clinicians select the more appropriate nitroimidazole for bismuth quadruple therapy in routine clinical practice.

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.

Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection

To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.

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 prevention of gastric carcinogenesis; and (2) earlier identification of premalignant gastric conditions, enabling appropriate surveillance endoscopy and earlier detection of gastric cancer. The primary endpoint is gastric cancer-specific mortality.

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 secondary outcomes include adverse events and treatment adherence.

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.

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

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, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen. Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication. Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days. Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication. Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up. Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.

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 rate in the era of increasing antibiotic resistance. susceptibility-guided tailored therapy (SG-TT) may be a good choice to solve this problem. The aims of this study are: 1. to compare the efficacy of SG-TT with GR-ET as rescue regimens for H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

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 and treatment. Researchers want to find out if these two non-invasive tests can be used together to create a reliable risk-scoring system. This system would help doctors quickly identify which patients are at a high risk for complications and need an urgent endoscopy, compared to those who are at a lower risk and can be safely monitored without the invasive procedure. The study will include adult patients presenting with stomach symptoms (like pain, nausea, or heartburn), as well as those with suspected or confirmed peptic ulcer disease. Participants will provide a blood sample to check for H. pylori antibodies and undergo a standard, painless abdominal ultrasound to examine the thickness of their stomach wall. An upper gastrointestinal endoscopy will be performed if it is clinically necessary as part of the patient's standard medical care.

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 broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible. Two different PAL generation modalities will be compared in this study: 1. HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach. 2. Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope. To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test. After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated. This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.

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 regimens? 2. What are the safety, adherence, and cost-effectiveness of the 7-day versus 14-day individualized regimens? Researchers will compare the 7-day course group and the 14-day course group to see if the 7-day course is non-inferior to the 14-day course in terms of eradication rate. Participants will: 1. Undergo fecal H. pylori drug resistance gene testing 2. Receive randomized assignment to either 7-day or 14-day individualized treatment based on drug susceptibility results 3. Complete follow-up visits at 1 week and 4-8 weeks after stopping treatment for adverse event monitoring and 13C-urea breath test

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.

P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Bismuth-containing quadruple therapy was recommended as a first-line treatment for Helicobacter pylori infection. This study aimed to compare real-world outcomes of various potassium-competitive acid blockers (P-CABs) -based bismuth quadruple regimens and identify factors influencing treatment failure. A multicenter cohort study was conducted and study outcomes included eradication rates and incidence of adverse events.

A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile

Gastric cancer remains a global health problem, and Chile has one of the highest GC mortality rates in the region. Helicobacter pylori (H. pylori) infection is ubiquitous in Chilean adults, and it constitutes the main cause of GC worldwide. A long-term process occurs from premalignant lesions to carcinoma. H. pylori eradication during early stages of disease significantly impacts outcomes, favoring survival, disease reversal and molecular changes, which supports a "screen and treat" strategy in asymptomatic populations in areas with intermediate-to-high GC prevalence. The Investigators' previous research has shown that H. pylori infection is acquired in early childhood with low rates of spontaneous eradication. A pilot treatment study in a subset of school-aged asymptomatic children showed a high rate of successful eradication (\>95%), good tolerance, and was associated with a decrease in serum biomarkers of gastric damage (pepsinogen I and II). Based on the results of these studies, the Investigators propose to advance towards the next stage of this research process: a "screen and treat" strategy. The current trial starts with a Screening phase testing up to 1000 asymptomatic adolescents 14-18 years of age from 3 cities of Chile (Colina, Temuco and Coyhaique), to find a total of 210 persistently-infected participants. Persistently-infected adolescents will be included in a Second phase of this trial: A randomized, case-control, non-blinded study to either receive antimicrobial treatment targeting H. pylori eradication (cases) or no treatment (controls). A subset of 60 non-infected adolescents will be followed-up in matched times. This aims to provide evidence on the effect of treatment on clinical outcomes and serum biomarkers related to gastric damage, as well as composition and antimicrobial resistance of gut microbiota. The Investigators expect that eradication therapy will be successful in \>90% of persistently infected adolescents, with reinfection rates not surpassing 15% in a 2-3 year period, and to be associated with a decrease in clinical findings indicative of gastric disease, and a decrease in serum biomarker indicative of "gastric damage".