Duodenal Ulcer

Gastric cancer is a serious health issue worldwide, with Chile experiencing some of the highest death rates. Helicobacter pylori infection is common among Chilean adults and is the main cause of gastric cancer. This research focuses on early detection and treatment of H. pylori infection in adolescents aged 14 to 18, aiming to reduce gastric damage and improve health outcomes by using a "screen and treat" strategy in areas with moderate to high gastric cancer rates. The study begins by screening up to 1000 asymptomatic adolescents in three Chilean cities to identify those persistently infected with H. pylori. Those confirmed with persistent infection will be randomly assigned to receive either a 14-day antimicrobial treatment including lansoprazole, amoxicillin, clarithromycin, and metronidazole, or no treatment. A group of 60 non-infected adolescents will also be followed for comparison. The study includes pre-treatment and multiple post-treatment evaluations over 18 months. Participants will undergo repeated urea breath tests to monitor infection status, gastroenterological exams, and collection of blood and stool samples to measure biomarkers of gastric damage and analyze gut microbiome changes. Researchers will assess the success of eradication therapy, reinfection rates, clinical signs of gastric disease, and changes in antimicrobial resistance and gut microbiota diversity. The total follow-up period includes regular check-ups up to 18 months post-treatment, with additional monitoring of non-infected participants.

Researchers are evaluating the effectiveness of human placental membrane products combined with standard care for treating nonhealing diabetic foot ulcers and venous leg ulcers. This multicenter, prospective, controlled trial follows a rescue design where patients who do not heal with standard care in a related trial may receive one of the study products. Patients must meet specific medical criteria for cellular or matrix-like products as outlined by Medicare guidelines. Participants are randomly assigned to receive one of several human amniotic membrane allograft products—Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Lite™, or Membrane Wrap-Hydro™—along with standard care. These products are applied weekly until the ulcer heals or up to a maximum of 12 weeks. The trial includes a rescue phase for those who fail to heal in the standard care arm of a previous related study. During the study, participants attend weekly visits for treatment application and monitoring. Researchers will assess wound closure percentage within 1 to 12 weeks as the primary outcome. Secondary measures include time to wound closure, area reduction, adverse events, quality of life improvements, and pain levels for those with significant pain. The total participation period may last up to 12 weeks, with regular evaluations to track healing and safety.

Researchers are evaluating the safety of vonoprazan exposure during pregnancy by comparing outcomes for pregnant women who take vonoprazan with those who do not but may use other treatments for similar conditions. The study focuses on maternal, fetal, and infant health, particularly monitoring for congenital malformations and various pregnancy outcomes related to erosive esophagitis, heartburn, symptomatic non-erosive gastroesophageal reflux disease, and Helicobacter pylori infection. The study includes two groups: pregnant women exposed to vonoprazan and those not exposed but possibly treated with other medications for related conditions. Vonoprazan is given as an oral tablet. Participants are observed from conception through pregnancy outcome, and infants are followed for up to 12 months after birth to assess health and development. Participants will provide consent and authorize their healthcare providers to share relevant data. Researchers will track major and minor congenital malformations, spontaneous abortion, stillbirth, elective termination, preterm birth, small gestational age at delivery, postnatal growth deficiencies, and developmental delays. Follow-up includes monitoring pregnancy outcomes and infant development for up to one year after birth, ensuring comprehensive safety evaluation over time.

This research aims to evaluate how artificial intelligence (AI) can help diagnose Helicobacter pylori infection and premalignant gastric lesions by analyzing upper endoscopic images. The study focuses on linking these images with urea breath test results and histopathological findings to improve diagnosis accuracy. The goal is to support clinicians, especially in rural areas, through a telemedicine system that assists in detecting these conditions and potentially links to gastric cancer risk. Participants undergo urea breath tests, upper gastrointestinal endoscopy, and histology examinations. The AI analyzes the correlation between the collected endoscopic images and the test results. This approach will be developed into a telemedicine service to assist healthcare providers in remote locations, such as the Matsu Islands. Throughout the study, researchers collect and review test results, endoscopic images, and histopathological data. They will measure how sensitive the AI is in detecting premalignant gastric lesions over up to five years and assess its ability to accurately exclude these conditions. The study runs until the end of 2026, allowing long-term follow-up and evaluation of the AI system's diagnostic performance.

Helicobacter pylori (H pylori) infection is a major cause of chronic gastritis and peptic ulcer disease, and it increases the risk of gastric cancer and certain lymphomas. About half of the Argentinean population is infected, but the best way to manage this infection is unclear. Treatments are often given without knowing the bacteria's resistance to antibiotics. This research aims to collect detailed information from Argentinean gastroenterologists about how they treat H pylori in routine practice to help identify the most effective therapies and improve antibiotic use. The study is a national, multicenter, prospective, non-interventional registry started in May 2021. It records data from adult patients treated for H pylori by gastroenterologists in Argentina. Researchers gather information on diagnosis, treatment types and doses, length of treatment, adherence, use of probiotics, side effects, and treatment outcomes. This registry collects real-world data without changing the care patients receive. Participants provide data through their doctors who routinely test for H pylori cure after treatment. The study measures include the effectiveness of eradication treatments at least 4 to 6 weeks after therapy, diagnostic methods, frequency of side effects, treatment effectiveness related to body mass index, and patient compliance during a 90-day follow-up. The study is ongoing with ethical approval and aims to improve understanding of H pylori management in Argentina.

Researchers are evaluating a new approach to protect the beneficial gut bacteria in people undergoing antibiotic treatment for Helicobacter pylori infection. This pilot study explores how preserving and then reintroducing a person’s own fecal microbiome could reduce side effects and prevent harm to important bacterial species during the standard 14-day antibiotic regimen used to eliminate H. pylori. The study is conducted in phases 1 and 2 to assess safety and effectiveness of this method. Participants will first provide a fresh stool sample before starting antibiotic treatment. They will then receive standard therapy to eradicate H. pylori for 14 days. After confirming eradication, participants will be randomly assigned to one of three groups: one group will receive their own microbiome transplanted back via capsules, another via enema, and a control group will receive placebo capsules. The fecal microbiome capsules are taken on two consecutive days after bowel preparation, while enemas are administered with nurse assistance and held for at least 15 minutes. During and after treatment, participants will be monitored through clinical visits where symptoms, side effects, and overall well-being will be recorded. Testing will confirm if H. pylori remains eradicated and measure restoration of gut bacterial diversity up to 18 weeks post-transplant. The study also tracks rates of re-infection and side effects over several months to understand the potential benefits and risks of this fecal auto-transplantation approach.

Researchers are evaluating the diagnostic accuracy of an AI-integrated Capsule Gastroscopy (ACG) system called GICE-1000 for detecting upper gastrointestinal (UGI) abnormalities in simulated home-use conditions. This study compares the ACG system's results to conventional esophagogastroduodenoscopy (EGD), the current gold standard, to determine if the ACG can be a reliable and comfortable alternative for screening gastric diseases. It also assesses if AI-assisted reading of ACG videos improves diagnostic accuracy or reduces reading time compared to manual review. Participants will undergo the ACG examination in a simulated home environment after fasting and taking medications to clear gastric mucus. They follow video instructions to swallow the capsule and adjust body positions during the procedure. The capsule data is uploaded for analysis. Within 24 hours, participants also receive an EGD performed by experienced endoscopists blinded to ACG results. The ACG videos are reviewed both manually and with AI assistance to document findings and compare reading efficiency. During the study, participants provide informed consent, undergo fasting and preparation, and complete both ACG and EGD procedures. Researchers collect detailed imaging data, record abnormalities, and evaluate factors such as image quality and gastric cleanliness. The main outcome is the diagnostic accuracy of ACG for common UGI abnormalities. Secondary outcomes include comparison of diagnostic time between AI-assisted and manual readings and other measures related to examination completeness, image quality, and participant satisfaction. The total study duration includes screening, intervention, and follow-up periods, ending with data analysis and reporting.

Acute Non-variceal Upper Gastrointestinal Bleeding (ANVUGIB) is a serious condition causing symptoms such as vomiting blood or passing black stools. Despite improved treatments, 10% to 30% of patients experience rebleeding soon after initial treatment, which raises the risk of death. Researchers are working to develop a new, more accurate prediction model to better identify patients at high risk of rebleeding compared to current tools like the Glasgow-Blatchford Score and Rockall Score. This model aims to help doctors make better decisions about preventive treatments and monitoring to reduce complications and improve outcomes. This observational study collects patient data during routine care to build and test this new prediction model. It will combine patient symptoms, lab test results, and imaging findings to improve risk assessment for rebleeding. Participants include adults diagnosed with ANVUGIB who receive an endoscopy within 24 hours of admission confirming non-variceal bleeding. The study focuses on evaluating rebleeding events within seven days of hospitalization. Participants will be monitored using data from their clinical care, including symptoms, lab tests, and imaging results. Researchers will measure the occurrence of rebleeding up to seven days after admission. No experimental treatments are given, and the study directly uses existing patient information to develop the prediction model. Participation involves routine procedures, and the study aims to improve future care by providing doctors with a better tool for identifying high-risk patients.

Researchers are studying the possible effectiveness and safety of combining Diosmin and Hesperidin in treating patients with Helicobacter pylori infection. The study focuses on evaluating how this combination affects the eradication of the infection as well as its impact on inflammatory markers such as TNF-A and MDA. This is a randomized, double-blind trial involving adult patients aged 18 to 75 years who have confirmed H. pylori infection. Participants are randomly assigned to one of two groups. One group receives the standard triple therapy consisting of Omeprazole, Clarithromycin, and Amoxicillin along with placebo tablets twice daily for 14 days. The other group receives the same standard triple therapy plus Diosmin/Hesperidin (Daflon) tablets twice daily for 14 days. Both treatments are administered orally. During the trial, patients are assessed at the start and six weeks after beginning therapy to measure the eradication rate of H. pylori infection using stool antigen tests. Researchers also measure levels of inflammatory biomarkers to observe any changes. Safety and response to treatment are monitored throughout the study, which lasts at least six weeks from therapy initiation.

Researchers are evaluating the effectiveness of multiple human placental membrane products, called CAMPs, combined with Standard of Care (SOC) versus SOC alone in treating nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This multicenter, prospective, randomized controlled trial uses a modified platform design to compare different CAMP products, including AM/Single and AM/Double, in promoting ulcer closure over 12 weeks. Participants will receive weekly treatments depending on their assigned group. The Standard of Care involves cleaning, debridement, moisture balance, and offloading or compression as appropriate. Those in CAMP groups will receive weekly applications of either AM/Single (a single layer human amniotic membrane allograft) or AM/Double (a double layer allograft) in addition to Standard of Care. Treatment continues until the ulcer closes or up to 12 weeks. During the study, participants will attend weekly visits for treatment and evaluation. Researchers will assess ulcer closure rates, time to closure, percent area reduction, pain changes, adverse events, and quality of life improvements over 12 weeks. The study monitors participants closely to measure healing progress and safety of the treatments throughout the trial duration.