Helicobacter pylori Infection

Researchers are evaluating the effectiveness and safety of a 7-day treatment combining vonoprazan, high-dose amoxicillin, and bismuth (VAB-7) to treat Helicobacter pylori infection. This infection can cause chronic stomach inflammation and increase risks for ulcers, lymphoma, and gastric cancer. The study compares this shorter regimen with the standard 14-day vonoprazan and high-dose amoxicillin dual therapy (VA-14) due to concerns about antibiotic resistance and the need for more effective treatments. Participants are randomly assigned to one of two groups. The experimental group receives vonoprazan 20 mg twice daily, amoxicillin 1 g three times daily, and bismuth 220 mg twice daily for 7 days. The control group receives vonoprazan 20 mg twice daily and amoxicillin 1 g three times daily for 14 days. The study explores whether adding bismuth can improve eradication rates in a shorter treatment course. During the study, researchers monitor participants for Helicobacter pylori eradication using a urea breath test conducted 4 to 6 weeks after treatment. They also assess patient adherence, adverse events during treatment days, and cost-effectiveness. Follow-up assessments occur shortly after treatment completion to evaluate safety and compliance. The total study duration for each participant varies based on their assigned treatment group.

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 four different treatment plans for Helicobacter pylori infection in Chinese children aged 6 to 18 years. This study aims to identify which regimen is best by comparing triple therapy, sequential therapy, bismuth quadruple therapy, and concomitant therapy. The study also investigates bacterial resistance, gene factors, and changes in gut microbiota to help develop new guidelines for treating this infection in children. Participants are randomly assigned to one of four groups receiving either triple therapy, sequential therapy, bismuth quadruple therapy, or concomitant therapy over a 14-day period. Each treatment group uses specific combinations of medications, including combinations of Omeprazole, Amoxicillin, Clarithromycin, Metronidazole, and Colloidal Bismuth Subcitrate. The study measures Helicobacter pylori eradication rates 4 to 6 weeks after treatment completion. Children in the study undergo tests including a 13C-urea breath test to confirm infection clearance. Researchers also assess side effects at 2 and 4 to 6 weeks after treatment, monitor changes in gut microbiome diversity at multiple time points, and analyze genes related to drug metabolism and bacterial virulence before therapy. Patient medication compliance is checked two weeks after treatment. The trial continues until the end of 2025, with detailed monitoring of treatment impact and safety.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are creating a registry to study people with early changes in the stomach lining that may lead to gastric cancer. This includes those with gastric atrophy, intestinal metaplasia, and dysplasia. The study also enrolls healthy individuals and people with gastric cancer to compare baseline characteristics and better understand risk factors for disease progression. Participants fall into three groups: those with specific stomach lesions, healthy controls, and people with gastric cancer. The study collects information through questionnaires about clinical history, environmental exposures, lifestyle, and diet. This observational study does not involve any treatment but gathers health data to support future research. Participants will complete questionnaires and provide health information over a period that may last up to 10 years. The main goal is to build a detailed participant registry. Researchers will monitor and analyze the collected data to identify factors related to the progression of stomach lesions to cancer. Participation involves regular data collection but no active treatment, with safety and privacy monitored throughout the study.

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.

Researchers are studying nutritional support strategies for critically ill patients with impaired gastrointestinal function, focusing on how to best achieve energy and protein intake goals. The study investigates the use of enteral nutrition alone versus a combination of enteral nutrition and supplemental parenteral nutrition (SPN) in patients who have impaired gastric emptying and reduced intestinal absorption. This research addresses the challenge of feeding intolerance and malnutrition in intensive care patients and explores muscle mass and function as important factors in nutrition efficacy. The study randomly assigns patients with diagnosed gastrointestinal dysfunction to one of two groups: one receiving gradual increases in enteral nutrition based on tolerance, and the other receiving a mix of enteral trophic feeding plus SPN to meet nutritional targets. Nutritional needs are monitored daily by indirect calorimetry, and gastrointestinal function is assessed with ultrasound gastric residual volume and a paracetamol absorption test. The SPN group aims to reach 80% of nutritional goals by day five, while the enteral nutrition group aims for full caloric intake as tolerated. Participants are monitored through various evaluations including muscle thickness via ultrasound, lean body mass by bioelectrical impedance analysis, and muscle strength with a handgrip dynamometer at admission and on days 10 and 15. The study measures daily calorie and protein intake adequacy, metabolic markers, and clinical outcomes such as mortality up to 28 days. Nutritional status, muscle function, and energy utilization are carefully assessed throughout the study to understand the impact of the tailored feeding protocols.

Researchers are conducting a prospective observational cohort study to compare the incidence of gastric cancer and the progression of gastric precancerous lesions among groups with different Helicobacter pylori (Hp) genetic subtypes. The study focuses on adults aged 40 and older who have a baseline negative gastric endoscopy and are either carriers of high-risk Hp SNP subtypes, non-high-risk subtypes, or are Hp negative. The goal is to understand how these genetic differences impact gastric cancer risk over time. Participants are followed prospectively in three groups: those who are Hp positive with high-risk SNP subtypes, those Hp positive with non-high-risk SNP subtypes, and those who are Hp negative. The study does not involve any treatment but monitors the natural progression of gastric conditions associated with these groups. Follow-up assessments occur over a period of up to 10 years, with primary and secondary outcomes measured at 3, 5, and 10 years. During the study, participants undergo baseline and follow-up examinations to monitor the incidence of gastric cancer and the development of precancerous lesions such as atrophic gastritis and intestinal metaplasia. Researchers also examine how factors like age, gender, diet, smoking, alcohol use, and family history might interact with Hp genetic risk. The primary outcome focuses on the difference in gastric cancer incidence among the groups during a 3-year follow-up, while secondary outcomes consider longer-term incidence and lesion progression. Participants' safety and ability to continue in the study are monitored throughout the follow-up period.

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.