Duodenal Ulcer

Background: Helicobacter pylori (H. pylori) infection is the main cause of gastric cancer (GC), and long-term process occurs from premalignant lesions to carcinoma. H. pylori eradication during early stages of disease in young adults ("screen and treat") significantly impacts GC favoring survival, disease reversal and molecular changes. Effects of eradication therapy in affecting gut microbiome diversity and composition, and increasing antibiotic resistance rates in commensal bacteria, appear to be transient in most studies. The investigators have shown that infection is acquired mainly during the first 5 years of life, most infected children remain persistently infected with low rates of spontaneous eradication and persistently infected children have more abdominal complaints and higher levels of pepsinogen (PG) II (marker of gastric damage). A pilot eradication trial in persistently infected school-aged children showed that with sequential triple therapy, eradication was achieved in 96.8% of children, and treated children had a decrease in PG I and II levels compared to non-treated. The Investigators propose a "screen and treat" strategy aimed at a transition age between childhood and adulthood, in areas with intermediate-high gastric cancer prevalence, to assess efficacy of eradication, its clinical and molecular benefits and potential microbial side effects. Aims: The primary aim will be to determine the effectiveness of H. pylori eradication therapy in 14-18 years old adolescents in three regions with nearly 20-25% persistence rates, and determine the effect of eradication on clinical and serum biomarkers of gastric disease/damage. The secondary aims will be to determine the effects of H. pylori eradication therapy on antimicrobial resistance of potentially pathogenic enteric bacteria, and on gut microbiome composition. Exploratory aims: To determine the presence of clarithromycin resistance genes in H. pylori by stool analysis of children not achieving eradication, and determine the effects of reinfection on clinical findings indicative of gastric disease, and biomarkers indicative of "gastric damage", gut microbiota composition and antimicrobial resistance of H. pylori and other potentially pathogenic bacteria. Methods: The Investigators will invite, through contact with the health and educational authorities of Colina, Temuco and Coyhaique, 14-18 year old students until we reach up to 1000 adolescents enrolled. H. pylori screening test (Urea Breath Test; UBT) will be offered, and adolescents with a positive test will undergo two additional tests, separated by 30 days, in order to confirm infection persistence (at least two positive tests). It is expected that 20-25% of adolescents screened to be positive for H. pylori, of which over 90% will be persistently infected. 210 Subjects with persistent infection will then be randomized 2:1 to receive either an antimicrobial course targeting H. pylori eradication (7 days of lansoprazole and amoxicillin followed by 7 days of lansoprazole and clarithromycin plus metronidazole) or no treatment. Participants will be followed-up with UBT (1 month post treatment, and then every 6 months for the remaining surveillance period), gastroenterological evaluation (2 weeks pre treatment, 1 month, 3 months, 9 months and 18 months post treatment), blood samples and stool samples (2 weeks pre-treatment, 1 month and 6 months post treatment). A subset of 60 non-infected students from each site will be followed-up in matched times. To those subjects with persistent infection who do not receive treatment, the same eradication regimen will be offered after they have completed the initial 6-month follow-up with their blood and stool samples taken. Serum gastric damage biomarkers will be assessed using GastroPanel® (PGI, PGII, Gastrin) and ELISA commercial kits (VCAM-1, CXCL13). Escherichia coli and Enterococcus spp will be cultured from stools samples, and resistance to 6 antimicrobials will be assessed by disk diffusion method. H. pylori clarithromycin resistance gene will be amplified from stools using nested-qPCR. Composition of gut microbiome will be characterized by amplification and sequencing the 16SrRNA gene from stools, ant then bioinformatics analysis. Expected results: The prevalence of persistent H. pylori infection will be around 20-25% in adolescents from Colina, Coyhaique and Temuco. Eradication will be successful in \>90% of persistently infected students, and reinfection rates will not surpass 15% in a 2-3 year period. Eradication will be significantly associated with a decrease in clinical findings indicative of gastric disease, and a decrease in biomarker levels indicative of "gastric damage". Treatment will have a transitory effect on increasing antimicrobial resistance rates of potentially pathogen enteric bacteria (Escherichia coli, Enterococcus spp.). Treatment will have a transitory effect on disrupting gut microbiota composition at phylum, class, order, family and genus levels, which will be restored to levels comparable to non-infected healthy teenagers at the end of follow-up. In those adolescents for whom eradication therapy fails, clarithromycin resistance will be more prevalent in pretreatment samples compared to those eradicating H. pylori; in reinfected children, treatment will have a transitory effect on increasing detection rates of H. pylori clarithromycin resistance genes.

This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).

The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are unexposed to vonoprazan during pregnancy but who may be exposed to other products for the treatment of conditions for which vonoprazan may be prescribed.

This study had invited patients to undergo urea breath test, upper gastrointestinal endoscopy, and histology examination. The study will collect their tests results, upper gastrointestinal endoscopy images, and histopathological results. Artificial intelligence techniques will be used to analyze the correlation between endoscopic images and urea breath test results/histopathological results. We aim to establish a telemedicine system to assist clinicians in diagnosing Helicobacter pylori infection and detecting premalignant gastric lesion using upper endoscopic images. The system will be implemented as a telemedicine service system in the rural areas, for example Matsu Islands. The baseline histological predictions will be linked to the newly incident gastric cancer.

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. 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. Recruiter Investigators The Recruiting Investigators must be gastroenterologists attending an adult population with a gastroenterology outpatient clinic that assists H. pylori infected patients. Before acceptance the outpatient clinic must attend, in a clinical routine basis, patients in which H. pylori diagnosis or treatment is indicated. Eradication confirmation tests have to be performed routinely. They will register the study variables of their own routine clinical practice in an e-CRF. Study Variables Anonymised Patient Identifiers Province/Centre/Investigator Gender Date of Birth Ethnic Background History and Comorbidity BMI Drug allergies Relevant comorbidities Current concomitant medication Data on Infection Indication for diagnosis and treatment Upper Gastrointestinal tract symptoms Diagnostic Test for current treatment Number and type of previous eradication attempts Prescribed Treatment Drugs Dosage and intakes per day Length of treatment Compliance Adherence to treatment (yes/no \>90%) Probiotics use Adverse Events Type of event, intensity, duration and relation with treatment Treatment withdrawal due to adverse events. Efficacy Eradication (yes/no), test used, and date

This is a pilot study. Prior to antibiotics therapy for their baseline H.Pylori infection, patients will be asked to deliver at least 50 grams of fresh stool to the Tel Aviv Medical Center (TLVMC) Bacteriotherapy Clinic. All patients will receive therapy to eradicate H. Pylori according to current guidelines (14 days) and physician's discretion, and will be tested to validate H. pylori eradication, at least 21 days post therapy (according to guidelines: Kyoto/ ACG/ Maastricht). For patients that H. pylori was not eradicated- a second line therapy will be administered according to guidelines, and stool will be retrieved at an additional time point, before FMT and after successful H. pylori eradication. Patients will be allocated into one of three groups: 1. Intervention group- patients will undergo Auto-FMT through capsules. 2. Intervention group-patients will undergo Auto-FMT through enema. 3. Control Group-patients will receive FMT through placebo capsules. Patients in Intervention group will undergo an additional breath test for H. Pylori, 14-28 days post FMT, to exclude H. pylori-self infection, by the FMT. This concern is related to the capsules therapy, although the fecal filtrate is double packaged in two capsules (one inside another) which are designed to dissolve only in the duodenum at a basic pH. If patients are found to be re-infected, they will undergo an additional antibiotics course and post eradication will receive FMT through an enema according to the above specified protocol. FMT capsules will be generated at the laboratory of the Gastrointestinal department at the Tel Aviv Medical Center. The same procedure for FMT generation will be used in this study as in other studies of the IBD unit and in the clinical Bacteriotherapy setting. FMT administration: 1. FMT through capsules (FMT/placebo)- patients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen capsules on two consecutive days. 2. FMT through enema- patients will evacuate the bowel prior to the procedure and will fast for 3 hours prior to the procedure . Patients will receive 80 ml of enema. Enemas will be administered with the assistance of the study nurse. Patients will be asked to hold the enema content for at least 15 minutes. At the post-FMT visit and follow -up visits, patients will be examined by a physician who will record clinical symptoms (abdominal pain, nausea, vomiting, weight change), adverse events (fever, abdominal pain, bloating, changes in bowel habits) and general well-being (quality of life and patient reported outcomes questionnaires).

Gastroscopy stands as the gold standard for diagnosis of upper gastrointestinal (UGI) diseases (1, 2). However, China faces a significant challenge due to its large population base and an insufficient number of gastrointestinal endoscopists, which limits the widespread adoption of conventional electronic gastroduodenoscopy (EGD). Additionally the discomfort associated with EGD and the low compliance rate reduce its effectiveness in meeting public health needs (3). Capsule endoscopy (CE), primarily comprising magnetic capsule endoscopy (MCE) and powerless capsule endoscopy (PCE), is an innovative medical technology that enables comfortable and comprehensive examinations of the digestive tract (4-6). MCE relies on costly magnetic guidance equipment for capsule manipulation (7), a process that requires specialized technicians. These inherent limitations pose barriers to its clinical use and acceptance in various settings, such as primary hospitals and community health centers. To overcome these challenges, we have developed an automated, wireless, artificial intelligent (AI) integrated Capsule Gastroscopy (ACG) System (GICE-1000, AI Mobile Gastroscopy, Guangzhou Side Medical Technology Co., Ltd) for detecting gastric lesions. After the stomach is distended with ingested, the capsule examines the entire stomach through standardised body position changes by the participant, eliminating the need for any magnetic guidance equipment. The video sequence can be viewed in real-time using a cellphone and transmitted via WIFI to a cloud server for remote reading. Characterized by its comfort, operational simplicity, and remote controllability, GICE-1000 is poised to enhance the early detection and treatment rate of UGI abnormalities in different settings, including both community hospitals and homes, thereby alleviating healthcare system burdens. However, there is no prospective study to assess the diagnostic accuracy of GICE-1000 in home scenarios. The study is structured into three distinct phases: the screening period, the examination period, and the follow-up period. 1. Screening Period: The investigators or research assistants will identify eligible participants, including patients and volunteers in the hospital, and provide a detailed explanation of the study, including relevant information and potential risks. Once a participant signs the informed consent form, the researcher will assign a screening number, record baseline demographic information, and evaluate eligibility based on the study's inclusion and exclusion criteria. Participants who meet the inclusion criteria and do not meet any exclusion criteria will be assigned an enrollment number. 2. Intervention Period: 2.1 Preparation One day prior to the examination, investigators or research assistants will instruct enrolled participants on preparation for the ACG examination. Participants will be advised to fast for 8 hours before the procedure but may drink clear, non-carbonated beverages. 2.2 Procedure of ACG examination 1. Thirty minutes before the examination, participants will report to the hospital's examination room, designed to simulate a home environment. Participants will watch an instructional video on a mobile device and ingest a streptozotocin granule-dimethylsiloxane suspension to clear gastric mucus and foam, improving visualization for the ACG examination. 2. Participants will undergo the ACG examination with video guidance from the mobile app for the ACG device. Following the video instructions, participants will connect the capsule to a mobile device, activate the capsule independently, and ingest it with water to begin the examination. Participants will adjust their body positions as instructed in the video until the examination is complete. Participants are not allowed to view the real-time videos of the ACG examination. During the procedure, researchers will only observe and record whether the participants complete the examination as instructed and note any adverse events. 3. After the ACG examination, the examination data will be uploaded to a cloud server or exported using the device manufacturer's reading system. 2.3 EGD examination 1. Participants should fast for at least 8 hours before the examination with clear water allowed, and take the streptozotocin granule-dimethylsiloxane suspension 30 minutes prior to the procedure. Anesthesia (either local or general) will be administered based on the patient's preference and clinical condition. 2. White-light EGD will be performed by endoscopists (with \> 500 EGD procedures performed) who are blinded to the results of the ACG examination results, within 24 hours after the ingestion of the capsule. The procedure for this study will adhere to the Systematic Screening Protocol for the Stomach (SSS), as outlined by Yao et al(8). This approach includes taking 22 standardized endoscopic photographs to ensure comprehensive visualization of the stomach. Additionally, at least 5 images will be captured from the esophagus, and 2 images will be obtained from the duodenum-one from the first portion (D1) and one from the second portion (D2). This ensures systematic and thorough documentation for diagnostic purposes. At least two images will be captured for each abnormal lesion: one from the top view and one from the side view. This dual imaging approach ensures comprehensive documentation of the lesion's characteristics, aiding in accurate diagnosis and assessment.Any abnormal lesions observed will be documented, including lesion location, morphology, number, type, estimated size etc. Biopsies or treatments will be performed, if necessary, after completion of the white-light EGD examination, following standard clinical practices. 3. Anonymous EGD reports, images, and videos will be exported from the Endoscopy Unit's database. 2.4 ACG reading The ACG video will first be reviewed by a capsule reader (with experience reading \>100 capsules) who is blinded to the EGD results at the center where the patient was enrolled (non-randomized). The initial reading will be conducted in standard mode, according - at 10 frames per s in single-view mode in the small bowel, and 20 frames per s in the oesophagus or stomach. Landmarks, including the first image of the gastrointestinal tract, the first stomach image, the first duodenal image, and representative images of anatomical structures (including esophageal, EGJ, gastric fundus, gastric angle, cardia, body, antrum, pylorus, 1st and 2nd part of the duodenum), were manually selected by the reader. Observed findings were recorded through mouse clicks, ensuring comprehensive documentation of the anatomical and pathological features identified during the video review. This systematic approach allowed for detailed tracking and analysis of abnormalities and structure coverage. The reader should record any abnormalities noted during the ACG video reading, and take at least one representative image of each lesion. The recorded data will include lesion location, morphology, number of lesions, type of lesion, a visual estimation of lesion size, and coverage of gastric anatomical structures (fundus, gastric angle, cardia, body, antrum, pylorus). Additional data will include timestamps captured at the start and end of the reading, image quality, gastric cleanliness, and the degree of gastric filling, among other factors. The ACG video will also be anonymized and randomly allocated to another center for blinded AI-assisted reading, with a reader (with experience reading \>100 capsules) who is unaware of the results from the initial manual reading and the EGD results. The reader will analyze the images and video data provided by the AI platform (Endonet) to make an AI-assisted diagnosis. Following the same documentation protocol as the manual reading, landmarks such as the first images of the gastrointestinal tract, stomach, and duodenum, as well as key anatomical regions (e.g., esophagus, EGJ, fundus, gastric angle, cardia, body, antrum, pylorus, D1 and D2) will be manually identified and captured through mouse clicks if available. Observations, abnormalities, and representative lesion images (at least one image for each lesion) will be recorded, along with lesion characteristics (location, morphology, number of lesions, type of lesion, estimated size), coverage of gastric anatomical structures (fundus, gastric angle, cardia, body, antrum, pylorus), overall image quality, cleanliness, and gastric filling, ensuring thorough documentation and analysis. The study is aim to compare the diagnostic accuracy and reading time of AI-assisted ACG reading with standard manual reading. The documented data will include lesion location, morphology, number of lesions, type of lesion, size, coverage of gastric anatomical structures (fundus, gastric angle, cardia, body, antrum, pylorus), as well as image quality, gastric cleanliness, and degree of gastric filling. Additionally, the number of AI-selected images and AI-assisted ACG reading time will be recorded. The diagnostic outcomes of EGD will serve as the reference standard for assessing the diagnostic accuracy of ACG (including AI-assisted ACG reading). 3\. Study Completion After the completion of all clinical trial cases, the researcher will retain the informed consent forms, review and finalize the case report forms, verify the accuracy and clarity of the data, complete data entry and verification, conduct statistical analysis, and prepare the clinical trial report.

ANVUGIB is a serious condition that can cause symptoms like vomiting blood or passing black stools. Although treatments have improved, about 10% to 30% of patients experience rebleeding shortly after their initial treatment, which increases the risk of death. Currently, doctors use tools like the Glasgow-Blatchford Score, Rockall Score, and AIM65 Score to predict how patients with ANVUGIB might recover. However, these tools are not very effective at identifying patients who are at risk for rebleeding. This study aims to create a new, more accurate prediction model to help doctors identify high-risk patients earlier. The investigators believe that a new predictive model, which combines patient symptoms, lab test results, and imaging findings, will improve the ability to identify patients at high risk of rebleeding compared to existing tools.The goal is to provide doctors with a more reliable tool to guide their decisions, such as when to give preventive treatments or increase monitoring. This could lead to better outcomes and reduce the risk of complications or death. This study uses patient data collected during routine care to develop and test the new model, ensuring the findings are directly applicable to real-world clinical settings.

This study intends to assess the possible effectiveness and safety of Diosmin and Hesperidin combination in patients with Helicobacter pylori Infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(TNF-A and MDA).

The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. This study will evaluate the clinical utility of multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.