[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"helicobacter-pylori-gastrointestinal-tract-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:helicobacter-pylori-gastrointestinal-tract-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100556749","h-pylori-eradication-with-argon-plasma-during-endoscopy-100556749",false,"NCT06529159","H. Pylori Eradication With Argon Plasma During Endoscopy","H. Pylori Eradication With Argon Plasma During Endoscopy (HEAPE)","HEAPE","Inclusion Criteria:\n\n1. Subjects must be 18 years or older\n2. Confirmed untreated H. pylori infection\n3. Able to understand and sign informed consent\n4. Available to return for all routine follow-up study visits\n5. Patients should have upper endoscopy scheduled according to latest guidelines, e.g., as a part of their diagnostic work-up of HP positive test, regardless of their decision to participate in the study.\n\nExclusion Criteria:\n\n1. Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure.\n2. Pregnancy or puerperium\n3. Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)\n4. Lactation\n5. An inability to provide informed consent\n6. Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.\n7. Hernias \u002F aspiration risk","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nTwo different PAL generation modalities will be compared in this study:\n\n1. 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.\n2. 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.\n\nTo 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.\n\nAfter 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.\n\nThis 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.",[27,28,29,30,31],"Helicobacter Pylori Infection","Helicobacter Pylori","Helicobacter Pylori Gastrointestinal Tract Infection","H. Pylori Infection","H. Pylori Gastrointestinal Disease",[33,34,35,36,37],"Urea Breath Test","Argon Plasma Coagulation (APC)","Endoscopy","Plasma Activated Liquid (PAL)","Plasma Medicine","RECRUITING","2026-02-26",{"date":41,"type":42},"2026-03-02","ACTUAL",{"date":44,"type":42},"2025-07-08",{"date":46,"type":21},"2027-12",{"name":48,"class":49},"Christopher C. Thompson, MD, MSc","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":50},"100615538","phase-2-vonoprazan-vs-proton-pump-inhibitor-with-vitamin-d-or-probiotics-based-triple-therapy-for-eradication-of-helicobacter-pylori-infection-100615538","NCT07293910","Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection","Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection","Inclusion Criteria:\n\n* Both male and female patients. • Patients ≥ 18 and \\\u003C80 years old.\n\nPatients with confirmed diagnosis of H. pylori infection using either stool antigen test, urea breath test or endoscopy.\n\nExclusion Criteria:\n\n* Pregnant or lactating patients. • Patients with inflammatory diseases. • Patients sensitive to any of the regimens' components. • Patients who had received a previous eradication therapy, recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month.\n\nPatients with previous incidents of gastric or duodenal bleeding, gastric surgery or gastric malignancy.\n\n• Patients with active liver disease.\n\n• Patients with renal impairment.\n\n• Concurrent use of liver enzyme inducers, inhibitors or drugs with high plasma protein binding.","80 Years",{"count":60,"type":21},66,[62],"PHASE2","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, gastric lymphoma, and gastric carcinoma. The current first-line treatment, a PPI-based triple therapy (PPI + clarithromycin + amoxicillin), is experiencing a decline in efficacy (cure rates of 50-70%) due to widespread antibiotic resistance and compliance issues. To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted. Vonoprazan works by reversibly inhibiting the H+, K+ ATPase pump achieving stronger and longer-lasting acid suppression than PPIs because it does not require acid activation and is more stable in an acidic environment. In addition to pharmacological treatment, adjunctive therapies show promise. Vitamin D, acting through Vitamin D Receptor (VDR), assists in eradication by upregulating antimicrobial proteins like beta-defensin and cathelicidin, and its metabolite can cause bacterial cell lysis. Probiotics (primarily Lactobacillus and Bifidobacterium strains) enhance eradication rates by restricting bacterial growth, inhibiting adhesion, and exerting an anti-inflammatory effect through decreased interleukin-8 production. Finally, helicobacter pylori infection is marked by significant inflammation and oxidative stress. The bacterial protein TIP alpha induces high levels of the pro-inflammatory cytokine TNF alpha. Furthermore, the infection increases free radical production, leading to oxidative stress reflected by high levels of malondialdehyde. Systemic inflammation is also evident as helicobacter pylori infection is associated with significantly elevated serum C-reactive protein levels, which decrease upon successful eradication.\n\nAim of the work:\n\nThis study aims at evaluating the safety and efficacy of Vonoprazan vs Proton Pump Inhibitor with Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection.",[65,66,29,67],"HELICOBACTER PYLORI INFECTIONS","Helicobacter Infection","Helicobacter Pylori Infected Patients",[28,69,70,71,72,73,74,75],"Vonoprazan","Vitamin D","Probiotics","Lactobacillus","C-reactive protein","Tumor necrosis factor alpha","Malondialdehyde","2026-02-11",{"date":78,"type":42},"2026-02-13",{"date":80,"type":21},"2026-02-15",{"date":82,"type":21},"2026-12-20",{"name":84,"class":49},"Tanta University"]