Clinical Research Directory

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 guideline-recommended first-line treatment regimens for H. pylori eradication. Treatment options for H. pylori vary considerably, with differing efficacy outcomes largely attributable to increasing bacterial antibiotic resistance. Furthermore, multiple factors influence the efficacy of H. pylori eradication, including smoking, body surface area, CYP2C19 gene polymorphisms, patient compliance, and regional variations. Therefore, to systematically evaluate the efficacy and safety of different treatment regimens alongside the cost-effectiveness of various therapeutic strategies, and to conduct ongoing critical analysis of clinical practice, this study proposes a long-term investigation of real-world clinical practice through a non-interventional cohort study registry. This will assess the effectiveness, safety, and temporal trends of different H. pylori infection treatment regimens, providing real-time evidence to support clinical practice.

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.

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.

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 risk of developing gastric cancer. This study will look at the prevalence of Helicobacter pylori infection in asymptomatic patients who have an additional gastroscopy during the same session as their screening colonoscopy. It will also record other early tissue changes or risk factors for stomach cancer, such as intestinal metaplasia and Barrett's mucosa. The main questions this study aims to answer are: * How often is Helicobacter pylori found in adults without upper gastrointestinal symptoms by use of OGD? * Are there any correlations between H. pylori infection and other risk factors, such as BMI, smoking, alcohol consumption, or a family history of colorectal and/or stomach cancer? About 1000 participants are expected to take part. Adults undergoing a screening colonoscopy at a private endoscopy center will be offered the chance to have an additional gastroscopy if they meet the study's inclusion criteria (no previous Helicobacter pylori infection and no upper gastrointestinal symptoms). Small tissue samples (biopsies) will be taken from the stomach and lower esophagus during the gastroscopy. Biopsies will be checked histologically for the presence of Helicobacter pylori and early tissue changes. During the gastroscopy, no additional procedures or biopsies will be done beyond what is normally performed during a routine examination. Everything done during this procedure follows the standard steps of a regular gastroscopy. All data will be coded to protect participant privacy. Researchers will use statistical methods to find out how common Helicobacter pylori infection is and whether it is related to other lifestyle or family risk factors or tissue changes.

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, 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. Aim of the work: This 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.

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 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

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 treating a common stomach infection caused by Helicobacter pylori (Hp) might improve metabolic health issues like high blood sugar, cholesterol problems, or obesity (collectively called metabolic syndrome). Specifically, it explores whether adding probiotics (good bacteria) or a natural compound called berberine (BBR) to standard Hp treatment can enhance these benefits by improving gut bacteria balance. 2. Who can participate? Patients: Adults aged 18-65 with both Helicobacter pylori infection (confirmed by a breath test) and newly diagnosed metabolic syndrome (based on waist size, blood sugar, cholesterol, or blood pressure). Healthy Volunteers: Adults aged 18-65 with no Hp infection and normal metabolic health (to compare results). Exclusions: Allergy to study medications (e.g., penicillin). Previous Hp treatment, recent antibiotic/steroid use, pregnancy, or serious medical conditions (e.g., liver/kidney disease). 3. What will participants do? Treatment Groups: Group A: Take two medications (vonoprazan + amoxicillin) for 14 days. Group B: Take the two medications + probiotics (Bifidobacterium tablets). Group C: Take the two medications + berberine (a plant-based supplement). Tests: Before treatment: Breath test, blood tests (blood sugar, cholesterol, inflammation markers), stool sample analysis (gut bacteria), and body measurements (weight, waist size). After treatment (1 month): Repeat tests to check Hp eradication and metabolic improvements. 4. Possible Benefits and Risks Benefits: Free Hp treatment and metabolic health monitoring. Potential improvement in blood sugar, cholesterol, or weight. Contribution to future treatments for metabolic syndrome. Risks: Mild side effects (e.g., nausea, diarrhea, stomach pain) from medications. Discomfort from blood draws or stool sample collection. 5. How are participants protected? All treatments are FDA-approved or widely used in clinical practice. Ethical review ensures participant safety. You can withdraw at any time without affecting your regular care. Information for Health Care Providers 1. Study Design Type: Prospective, single-center, open-label, randomized controlled trial. Population: 140 participants (120 Hp+ patients with metabolic syndrome; 20 Hp- healthy controls). Intervention: Group A: Vonoprazan (20 mg bid) + amoxicillin (1 g tid) for 14 days. Group B: Group A + Bifidobacterium tetragenous probiotic (3 tablets tid). Group C: Group A + berberine (3 tablets tid). Primary Outcomes: Hp eradication rate (confirmed by urea breath test). Changes in metabolic parameters (fasting glucose, HbA1c, lipid profile). Gut microbiota composition (16S rRNA sequencing). Secondary Outcomes: Multi-omics analysis (inflammation markers, endotoxins, short-chain fatty acids, bile acids). 2. Scientific Rationale Hp and Metabolic Syndrome: Epidemiological evidence links Hp infection to metabolic dysfunction, possibly via chronic inflammation. Eradication may partially reverse insulin resistance and dyslipidemia. Gut Microbiota as Mediator: Hp eradication alters gut microbiota, which regulates metabolic homeostasis through metabolites (e.g., SCFAs), bile acid metabolism, and inflammatory pathways. Probiotics/BBR may enhance these effects. 3. Methodology Randomization: Block randomization (block size = 4) using SAS 9.4. Assessments: Metabolic Parameters: Fasting glucose, HbA1c, lipid profile, BMI. Microbiome: 16S rRNA sequencing (α/β diversity, taxa abundance). Multi-omics: ELISA (TNF-α, IL-6), GC-MS (SCFAs), UPLC-MS (bile acids). Statistical Analysis: Microbiome: QIIME2, LEfSe, PICRUSt2. Multi-omics: limma, SparCC, sPLS-DA. Clinical data: ANOVA, χ² tests (SPSS v25.0). 4. Clinical Implications Clarify whether probiotics or BBR add value to Hp eradication in improving metabolic health. Identify gut microbiota-driven mechanisms linking Hp eradication to metabolic benefits. Resources for Participants Study Flowchart: Screening: Breath test, blood/stool tests (1 week). Treatment: 14 days of medication. Follow-up: Repeat tests at 1 month. Contact Information: Dr. Wanli Liu: +86-18951670222 Nanjing First Hospital Gastroenterology Department. FAQ Sheet: Can I take my regular medications? Yes, unless they interfere with Hp treatment (e.g., PPIs). What if I miss a dose? Contact the study team immediately. Ethical Compliance Approved by the Institutional Review Board of Nanjing First Hospital. Complies with the Declaration of Helsinki and China's ethical guidelines. Informed consent required for participation.

Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection

this Study Evaluating Safety and Effectiveness of (Proton Pump Inhibitor versus Vonoprazan) Based Triple Therapy with or without Zinc to Eradicate H. pylori Infection

miRNA in Pediatric Gastritis

The goal of this clinical trial is to assess the differential expression of miR-155 and miRNA-204 in relation to gastritis, and assess their relation with the presence of H. pylori in children.

Prevalence of Helicobacter Pylori on Patients With Chronic Inflammatory Bowel Disease (IBD) at the CHU of Guadeloupe

Clinical and experimental data suggest that dysbiosis may play a pivotal role in the pathogenesis of intestinal bowel disease (IBD). However, to the best of our knowledge, the composition of gastric and of intestinal microbiome has never been investigated in a population with IBD according to the presence/absence of Helicobacter pylori (H. pylori) in the stomach.

Lignin in Treatment of Helicobacter Pylori Infection

The goal of this clinical trial is to learn if drug hydrolyzed lignin works to treat H pylori infection in adults. It will also learn about the safety of drug lignin n the sitting of H pylori infection, and if it halts the side effects associated with H pylori triple therapy. The main questions it aims to answer are: * Does drug hydrolyzed lignin improve the H pylori eradiation rate when it is added to the standard triple therapy used in treatment of H pylori? * What medical problems do participants experience when taking drug hydrolyzed lignin? Researchers will compare drug hydrolyzed lignin to a placebo (a look-alike substance that contains no drug) to see if drug hydrolyzed lignin works to treat H pylori. Participants will: * Take drug hydrolyzed lignin or a placebo every day for 2 weeks beside the standard triple therapy * Visit the clinic once every 1 week for checkup and questionnaire filling * Check for H pylori eradication after treatment

Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）

This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin. One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount. A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

Feasibility Study to Diagnose Helicobacter Pylori in the Paediatric Population Using Non-invasive Fecal Analysis

Helicobacter pylori infection is a widespread bacterial disease affecting nearly half of the world's population. In children, the infection displays distinct features versus adults, with lower prevalence, variable symptoms, and differing endoscopic and histological appearances. Typically acquired in early childhood, its transmission is closely linked to socio-economic disadvantage and overcrowding. Although most infected children are asymptomatic, some develop epigastric pain, dyspepsia, weight loss, or other gastrointestinal disturbances. Chronic infection may eventually lead to mucosal atrophy and intestinal metaplasia, increasing the risk of gastric cancer later in life. Given the limitations and risks of invasive diagnostic methods-especially endoscopy under general anesthesia-there is a critical need for reliable, non-invasive tests. Recent adult studies indicate that stool-based PCR is a promising alternative for both detecting H. pylori and identifying clarithromycin resistance. The primary objectives of this study are to evaluate the intrinsic diagnostic performance of high-resolution melt PCR (HP PCR) in stools, and to compare these results with those obtained from a conventional work-up, such as gastric biopsies, in a paediatric population. In accordance with prevailing rationality, the principal outcome of this study will be an evaluation of the intrinsic diagnostic capabilities of the proposed method. This will be accomplished by conducting a comparison of the sensitivity and specificity of the PCR test in stools with those of gastric biopsies (reference test).

to Assess the Eradication Rate of 14-day Bismuth/Amoxicillin/PCAB Triple Therapy for the Treatment of Helicobacter Pylori Infection

To assess the efficacy and safety of 14-day bismuth/amoxicillin/PCAB triple therapy for the treatment of Helicobacter pylori infection in Taiwan

Efficacy of Vonoprazan-based Rescue Therapy for H. Pylori Eradication

1. This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori. 2. We also plan to explore the impact of eradication therapy on gut microbiota, fecal antibiotic resistance, and metabolic parameters before and after treatment.

Effect of H.Pylori Infection on Growth Parameters

This study aimed to assess the effect H.pylori infection on growth parameter Of primary school-aged children Attending Assuit university chilren hospital

Low-Dose Amoxicillin Dual-Therapy Combined with Licorice and Lotus Root Powder Helicobacter Pylori Treatment

In recent years, the increasing prevalence of Helicobacter pylori (H. pylori, Hp) resistance has led to a gradual decline in the eradication rate of Hp. The growing resistance to antibiotics, particularly clarithromycin, has severely impacted the efficacy of Hp eradication. Dual-therapy regimen consisting of a proton pump inhibitor (PPI) and amoxicillin can overcome clarithromycin resistance in Hp and is effective for Hp treatment. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), has a stronger and more sustained inhibitory effect on gastric acid secretion compared to traditional PPIs. Dual-therapy regimens combining P-CABs and high-dose amoxicillin have demonstrated high eradication rates. However, the adverse effects associated with high-dose amoxicillin, such as nephrotoxicity, limit the application of this regimen. Our recent in vitro bacterial experiments and animal studies have shown that licorice, a traditional Chinese herbal medicine that is also used as a food, can inhibit the growth of Hp. This study is designed to compare a licorice-containing treatment regimen with a low-dose amoxicillin dual-therapy regimen in a clinical RCT to explore the efficacy of the former in Hp infection treatment.

Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women to Determine Whether H. Pylori Infection is Associated with Elevated Prolactin Levels and Assess the Clinical Implications

The research is a cross-sectional observational study conducted at Assiut University Hospital. It will involve 75 women aged 18-45 with confirmed H. pylori infection. The study will measure serum prolactin levels and H. pylori infection status through stool antigen tests. The primary outcome is comparing prolactin levels between H. pylori-positive and negative women. Secondary outcomes include analyzing correlations with clinical symptoms and demographic factors.

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.

Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication

The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.