Clinical Research Directory

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.

Effect of Simethicone on Helicobacter Pylori Detection in Routine Endoscopy

Rationale: Although simethicone improves mucosal clarity, in vitro evidence suggests that its surfactant properties may disrupt bacterial adherence or viability. These findings raise concerns that simethicone may negatively affect the sensitivity of endoscopic-based H. pylori diagnostic methods. To date, no prospective in vivo study has evaluated whether simethicone influences H. pylori detection through endoscopic sampling. This randomized paired trial is designed to address this gap in evidence and evaluate whether simethicone administration reduces diagnostic yield. Hypothesis: Simethicone administration prior to upper gastrointestinal endoscopy may reduce the detection rate of H. pylori by interfering with bacterial detection and diagnostic test performance. Note on Pilot Study Design: This is a pilot study conducted to test feasibility and inform the design of a larger future trial. Objectives: To evaluate whether oral administration of simethicone prior to endoscopy reduces the diagnostic yield of H. pylori using the rapid urease test (RUT). To evaluate whether oral administration of simethicone impacts the detection of H. pylori by other diagnostic methods, including histology, PCR, culture, and urea breath testing performed during endoscopy. To explore variability in detection methods and determine feasibility for a future larger trial.

Efficacy of Carminal in Helicobacter Pylori Gastritis

Eighty patients will be included and randomized in two groups, one group (40 patients) will be administered 30 ml of the supplement Carminal, once a day, plus therapy for HP gastitis and the control group (40 patients) will be given standard therapy for HP gastritis with placebo. Treatment will begin after complection of upper endoscopy with histology results from biopted gastric mucosa. Treatment with Carminal will be continued after successful HP eradication during 12 weeks. The final evaluation will take place 12 weeks after the last Carminal intake, when control endoscopy with histology will be performed. The study will last approximately 24 weeks.

Argentinean Registry on the Management of Helicobacter Pylori Infection

Helicobacter pylori (H pylori) is the main cause of chronic gastritis and peptic ulcer disease. In addition, is the main risk factor for gastric adenocarcinoma and mucosa-associated lymphoid tissue lymphoma. It is estimated that around 50% of the Argentinean population is infected with H pylori. The optimal management of H pylori remains unclear. In Argentina, most treatments are prescribed on an empiric basis, unaware of the bacterial antibiotic resistance profile. Meta-analysis showed that susceptibility-guided treatment is not better than empirical treatment in first and second line treatment therapy if the most effective local regimens are prescribed. Updated information concerning local data is needed to design the best strategy to treat H pylori infection in order to reach high eradication rates and to introduce the principles of antimicrobial stewardship to reduce inappropriate antibiotic use. The Argentinean Registry on H pylori (ArgReg-Hp) management was launched in May 2021 in order to obtain a large and representative sample of routine clinical practice of Argentinean gastroenterologist. Its main focus was to identify therapies that are highly effective and can be used empirically. Test of cure data is a surrogate method for susceptibility testing and resistance Primary aim To obtain a database registering systematically of a large and representative sample of routine clinical practice of Argentinean gastroenterologists in order to produce descriptive studies of the management of H. pylori infection. Secondary aims To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori. The Argentinean Registry on H pylori management is a National , multicenter, prospective, non interventional registry recording data on H pylori management since May 2021. The ArgReg-Hp is promoted by Instituto de Investigaciones Médicas Alfredo Lanari (IDIM), Universidad de Buenos Aires and Club Argentino Estómago y duodeno (CADED). Ethics: ArgReg-Hp was approved by the Ethics Committee IDIM, University of Buenos Aires as the reference IRB, and was approved by each center participant

H. Pylori Screen-and-treat Study in a Population of Young Adults

Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia. Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up. Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.