45 Clinical Trials for Various Conditions
Background: Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori. Objective: To compare the esophageal string test (EST) to standard tests for detecting H. pylori infection. Eligibility: People aged 18 years or older with persistent H. pylori infection. Design: Participants will have 3 or 4 clinic visits over 2 to 4 months. Screening visit: Participants will have a physical exam. They will provide a stool sample. Baseline visit: Participants will have blood tests. Then they will have the EST: One end of a string will be taped to the outside of their cheek; the other end will be packed into a capsule. Participants will swallow the capsule, and the string will unwind down their throat into their stomach. The string will be left in for at least 1 hour. Then researchers will gently pull out the string. The fluids soaked into the string will be studied. Some participants will be prescribed antibiotics. Follow-up visit 1: Participants whose H. pylori infection was cured by the antibiotics may leave the study. Those who are still infected will have an endoscopy: A flexible tube will be inserted down the throat and into the stomach. It will take tissue samples from the stomach lining. These participants will then receive antibiotics again. Follow-up visit 2: The physical exam, blood test, and stool sample will be repeated. ...
Helicobacter Pylori
The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible. Two different PAL generation modalities will be compared in this study: 1. HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach. 2. Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope. To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test. After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated. This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.
Helicobacter Pylori Infection, Helicobacter Pylori, Helicobacter Pylori Gastrointestinal Tract Infection, H. Pylori Infection, H. Pylori Gastrointestinal Disease
A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban New York City population.
Helicobacter Pylori Infection
To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.
Helicobacter Pylori Infection
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients against an active comparator.
Helicobacter Pylori Infection, Dyspepsia
This study is an etiologic trial to test the hypothesis that predicts that Helicobacter pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body iron. The study will assign and aims to complete the follow-up of 240 subjects half of them assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested the effectiveness of this therapy in the study population and it seems to yield almost 100% eradication on PP analysis. We need the best possible, near 100% eradication rate, which we have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H pylori leads to a deficit of body iron.
Helicobacter Pylori Infection
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer, Loss of Appetite, Bloating
The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer, Loss of Appetite, Bloating
The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
Helicobacter Infections
Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems, including stomach cancer. Researchers want to look at samples of the bacteria. These H. pylori strains will be taken from chronically infected people. They want to identify the genetic and epigenetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get stomach cancer. This could lead to the cancer being detected earlier. It could also mean less people get stomach cancer. Objectives: To study genetic variations of H. pylori strains based on samples from chronically infected people. To identify the features of strains that might lead to severe stomach problems or stomach cancer. Eligibility: People ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer Design: Participants will be screened by the doctor who does their procedure and a study nurse. Participants who have endoscopy will have \~6 biopsies removed. These are tissue samples. They are about the size of a grain of rice. Participants will allow the study team to access reports from their stomach exam. Participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. They will allow the study team to access reports of their surgery. They will also allow them to access the microscope slides of their stomach.
Gastric Cancer, Non-Atrophic Gastritis, Intestinal Metaplasia
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.
Helicobacter Pylori Infection
This is a research study for patients who currently have or previously had an H. pylori infection or who have gastric or esophageal cancer and who plan to undergo an endoscopy as part of their care. The purpose of this study is to find out how and why H. pylori infections can cause progression to gastric cancer and if it's possible for intervention prior to this progression.
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
Helicobacter Pylori Infection
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients.
Dyspepsia, Helicobacter Pylori Infection
Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.
Helicobacter Infection
The purpose of this study is to confirm equivalence of a new generation breath analyzer (Modified BreathID) in its ability to detect H. pylori compared to the currently approved BreathID® System.
Suspicion of Being Infected With H.Pylori
This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori) colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban academic emergency department (ED) located in Washington, DC.
Gastritis, Peptic Ulcer, Peptic Ulcer Perforation, Stomach Ulcer
The purpose of this study is to determine if the bacteria that cause gastric infections can be found in the mouths of intellectually and developmentally disabled persons. If the bacteria that causes gastric infections is found in the mouth it may be swallowed and contribute to gastric infections.
Helicobacter Pylori Infection
Cystic fibrosis (CF) is the most common lethal autosomal recessive disease among Caucasians. While the pulmonary disease in CF receives most of the attention, gastrointestinal diseases occur in \>95% of CF individuals and can contribute to significant morbidity, mortality and a decreased quality of life. The abdominal pain in CF is usual chronic in nature, and the etiology is not usually found, despite medical testing for standard causes of abdominal pain. Helicobacter pylori (Hp) is increasingly being recognized as the etiology of peptic ulcer disease and other upper and lower gastrointestinal tract diseases.1 The role that Hp plays in CF abdominal pain has not been elucidated. Our long-term goal is to understand relationship between chronic HP infection and abdominal pain in pediatric CF patients. The specific objective of this proposal is to utilize current state-of-the-art testing for HP to determine the prevalence of Hp in our CF patients age 5 and older. The central hypothesis is that Cystic fibrosis subjects with significant abdominal pain will have an increased incidence of Helicobacter pylori as determined by the urea breath test and stool antigen test. The rationale for the proposed research is that once we elucidate a causal relationship between CF patients with abdominal pain and Hp, we can begin treatment of this infection to improve quality of life.
Cystic Fibrosis, Abdominal Pain, Helicobacter Pylori Infection
The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
Helicobacter Pylori Infection
The purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.
Parkinson's Disease, Helicobacter Infections, Motor Fluctuations
The study proposes to test whether chronic infection with Helicobacter pylori protects individuals from symptomatic infection with enteropathogenic E. coli. The study will also evaluate the effect of gastric acidity in this relationship.
Infection, Achlorhydria
This study will examine bacteria and toxins in the mouth, lung and digestive system that may be the cause of various diseases or symptoms. H. pylori is a bacterium that produces various toxins that may contribute to lung problems. This study will examine specimens collected from the mouth, teeth, lung, digestive tract and blood to measure H. pylori and its toxins and their effects on cells. People 18 years of age and older with or without gastrointestinal disease may be eligible for this study. These include people without a history of lung disease as well as patients with any of the following: lymphangioleiomyomatosis, asthma, sarcoidosis, other chronic or genetic lung disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis or eosinophilic granuloma). Participants may undergo the following tests: * Blood and urine tests, chest x-ray. * Measurement of arterial blood gases: A small needle is placed in an artery in the forearm to collect arterial blood. * Lung function tests: Subjects breathe deeply and occasionally hold their breath. They may also receive a medication that expands the airways. * Fiberoptic bronchoscopy with lavage and bronchial brushing: The subject's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways. Saline (salt water) is then injected through the bronchoscope into the air passage and then removed by gentle suction. Next, a small brush is passed through the bronchoscope and an area of the airway is brushed to collect some cells for examination. * Mouth rinsing or teeth brushing to collect cells. * Endoscopy: A small needle and catheter (thin plastic tube) are placed into an arm vein to administer fluids and medications through the vein. A sedative may be given. The throat is numbed with lidocaine and a thin flexible tube called an endoscope is inserted through the mouth and down the esophagus into the stomach and upper part of the small intestine to examine those areas.
Pulmonary Disease, Oropharyngeal Disease, Lymphangioleiomyomatosis, Pulmonary Fibrosis, Asthma, Sarcoidosis
The investigators hypothesize that the Helicobacter pylori bacterium decreases iron from the stomach and that this effect of the infection can be identified among persons with iron deficiency as well as among persons with normal iron stores. The aim of this study is to determine whether Helicobacter pylori eradication in children is followed by an increase in markers of iron stores after six to twelve months of treatment.
Iron Deficiency
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
Helicobacter Pylori
Helicobacter pylori (Hp) is a major cause of chronic-active gastritis and primary duodenal ulcers, and is strongly linked to gastric cancer. Most Hp infections worldwide are acquired in childhood. Why some individuals develop symptomatic disease is unclear and, until recently, no studies critically evaluated the role of pediatric Hp strains and/or host factors in disease outcomes. Over the past 5 years of National Institutes of Health (NIH) funding, 486 children from Atlanta, Cleveland, and Miami were enrolled; 184 (38%) were Hp-infected. Race (African American) and younger age, in conjunction with Hp strains expressing cagA and vacAs1B, were shown to be risk factors for both esophageal and gastric disease, suggesting a different disease paradigm from Hp-infected adults. Using the updated Sydney system, the investigators demonstrated a histopathologic spectrum in children, which included novel observations of atrophic gastritis with intestinal metaplasia. Overall hypothesis for competitive renewal: disease manifestations in Hp-infected children are influenced by specific host factors (i.e., race, immune phenotype), environmental exposures, and specific virulence factors of infecting Hp strains. Specific aims: 1. Using well defined cases and controls, further characterize specific host factors and environmental exposures contributing to symptomatic childhood infection emphasizing targeted enrollment in specific age, gender and demographic strata to facilitate detection of significant differences not attained previously and follow-up of 2 established specific cohorts to ascertain immune response natural history. 2. Utilize gene-array technology for the whole Hp genome assessment and bacterial gene expression of specific virulence determinants associated with pediatric Hp strains. 3. Further characterize the host immunologic and mucosal response in Hp-infected children. Hp-infected symptomatic endoscopy cases at the investigators' established 3 clinical centers of high, moderate and low Hp prevalence will be compared with age-matched Hp-infected asymptomatic and uninfected symptomatic controls. Two geographically and demographically distinct centers have been added to provide additional geographic and subject representativeness to the patient cohort. The updated Sydney system will be employed to assess gastric histopathology severity and phenotype in newly enrolled cases in specific age, gender and demographic strata and follow-up of the two "novel" cohorts established in the past 5 years: a) atrophic gastritis; and b) esophageal and gastric disease groups enabling a comprehensive, multivariate evaluation of the natural history of Hp-infected children in two distinct disease paradigms. Using molecular methods (multiplex \[MP\]-PCR, RT-PCR) and a micro ELISPOT assay on peripheral blood mononuclear cells (PBMCS), Th1, Th2, Th3 or balanced Th1/Th2 response will be determined to further characterize the Hp-infected child's immune response phenotype. The investigators propose to further their previous work with critically lacking studies from a multivariate approach, leading to a better understanding of the gastroduodenal disease sequelae and overall pathobiology of Hp infection in humans.
Helicobacter Infections, Gastritis, Peptic Ulcer
The purpose of this study is to determine if Helicobacter pylori (H. pylori) gastritis results in abnormal iron metabolism in patients with iron deficiency anemia (IDA), and to determine if this is due to strain variations in the H. pylori organism.
Iron Deficiency Anemia, Helicobacter Pylori Infection
The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
Helicobacter Infections
This study will examine whether infection with Helicobacter pylori bacteria may cause inflammation of the eye's surface. Although most people who are infected with H. pylori do not have symptoms, the bacteria can cause several diseases, including gastritis-stomach inflammation, stomach ulcers or, rarely, stomach cancer, and certain types of lymphoma. H. pylori has also been associated with autoimmune disorders, in which the patient's immune system attacks the body's own tissues. People who have been infected with H. pylori, with and without dry eye, may be eligible for this study. Candidates are screened with a medical history, a blood test to determine H. pylori infection, and an eye examination. The examination includes measurements of visual acuity, eye pressure, and tear production. To measure the amount of tear production, a small piece of filter paper is inserted over the eyelid on the side and collects tears over a 5-minute period. Drops of two colored dyes (orange and green) are placed in the eyes to see if there are any dry areas. Screening also includes examination of the pupils and eye movements, the lens, and the back of the eye, including the retina. Participants will also have a few cells collected from the surface of the eye. After the eyes are numbed with anesthetic eye drops, a swab (like a Q-tip) is rolled over the surface of the white part of the eye to collect small samples of the superficial layer of the conjunctiva - a transparent membrane covering the eyeball. The specimens are analyzed by special laboratory techniques to determine whether H. pylori has infected the eye.
Helicobacter Infections
This observational epidemiologic study with nested cross-sectional and longitudinal aims will evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent tuberculosis, intestinal helminthiasis) in recent US immigrants.
Communicable Diseases