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Helicobacter Pylori Infection clinical trials

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NCT ID: NCT05787262 Recruiting - Clinical trials for Helicobacter Pylori Infection

Clinical Utility of Upper Endoscopy in Diagnosis of Helicobacter Pylori Infection

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Helicobacter pylori (H. pylori) is a gram-negative flagellated bacterium that inhabits the gastric environment of 60.3% of the world population, and its prevalence is particularly high in countries with inferior socioeconomic conditions, exceeding 80% in some regions of the globe , This phenomenon occurs among other reasons, due to the unsatisfactory basic sanitation and high people aggregations observed in many under developed nations, scenarios that favour the oral-oral and fecal-oral transmissions of H.pylori.Another possible transmission route of this pathogen is the sexual route. Several studies have shown that the colonization of H.pylori could be negatively and positively associated with the induction and progression of several diseases .It has been reported to be linked to gastric and duodenal ulcer, gastric carcinoma, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma and gastritis ,A positive association also reported between H.pylori infection and oesophageal cancer. Moreover, evidence is also available on the positive association between H.pylori and non gastrointestinal diseases such as diabetes mellitus , coronary artery disease , and anaemia. Abdominal pain and discomfort, nausea, burping, and loss of appetite are common symptoms of H.pylori infection. Other symptoms include, bloating, weight loss, and heart burn. Several approaches are used in the detection of H. pylori. Both the invasive and the non-invasive methods are employed in the detection of H. pylori in a patient. Many factors, however, influence choices in the method of diagnosis: availability of diagnostic instruments/materials, sampling population, and competency and experience of the physicians/clinicians . Invasive methods include endoscopic evaluation, histology, rapid urease test (RUT), and bacterial culture. Non-invasive methods include urea breath test (UBT), stool antigen test (SAT), serology, and molecular diagnostic approaches .Endoscopy is an accurate test for diagnosing the infection as well as the inflammation. Endoscopy also allows the determination of the severity of gastritis with biopsies as well as the presence of ulcers, MALT lymphoma and cancer. Real-time endoscopy along with conventional white light imaging (WLI)and image enhanced endoscopic (IEE)techniques, such as narrow-band imaging (NBI), linked color imaging (LCI) and blue laser imaging (BLI), appear to have important roles in clinical practice to identify H. pyloriinfected status . Another endoscopic technique is i-scan digital chromoendoscopy, which is a digital contrast method that enhances minute mucosal structures and subtle changes in color . The overall diagnostic accuracy of i-scan is 97% compared to 78% for WLI .

NCT ID: NCT05775120 Recruiting - Gastric Cancer Clinical Trials

Epidemiology of Helicobacter Pylori Infection in Moscow

Start date: July 1, 2022
Phase:
Study type: Observational

H. pylori is transmitted from individual to individual and causes chronic active gastritis in all infected people. H. pylori infection can result in gastroduodenal ulcers, atrophic gastritis (AG), gastric carcinoma, and gastric MALT lymphoma. More than 90% of gastric carcinomas are linked to H. pylori infection that causes chronic AG. A long course of the disease leads to the loss of gastric glands (chronic AG) followed by gastric intestinal metaplasia (GIM), dysplasia, and cancer. This defines two cancer prevention strategies: primary that consists of detection and eradication of H. pylori and secondary that focuses on endoscopic screening for pre-neoplastic lesions and follow-up. Primary prevention planning requires reliable information on the H. pylori prevalence in the population. To design secondary prevention measures, an understanding of the age-sex structure of precancerous changes in the gastric mucosa (the prevalence of atrophic gastritis) is necessary. H. pylori eradication is the basis of primary prevention of gastric cancer (GC). Approximately 36,000 new cases of GC are registered in the Russian Federation each year, and more than 34,000 patients die from the disease. Men get sick 1.3 times more often than women, the peak incidence occurs at the age of over 50 years. The poor outcomes reflect the late stage of diagnosis of this potentially preventable and treatable cancer. The lack of up-to-date data on the H. pylori prevalence in Moscow hinders developing of measures for the detection and timely treatment of this infection as well as the reduction of GC morbidity and mortality.

NCT ID: NCT05762991 Recruiting - Clinical trials for Helicobacter Pylori Infection

Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion

Start date: December 24, 2021
Phase:
Study type: Observational

The aim of this diagnostic accuracy study is to evaluate the application of artificial intelligence on the diagnosis of Helicobacter pylori infection and premalignant gastric lesions based on upper endoscopic images. We use techniques of artificial intelligence to analyze the correlation between endoscopic images and urea breath test results/histopathological results.

NCT ID: NCT05749081 Active, not recruiting - Clinical trials for Helicobacter Pylori Infection

Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy

Start date: May 13, 2023
Phase: Phase 4
Study type: Interventional

Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., <90%) when given as first-line treatment for H. pylori infection. Lacidophilin tablets have been reported to increase the eradication rate of H. pylori while reducing the incidence of adverse effects.This study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H. pylori in China.

NCT ID: NCT05742568 Recruiting - Gastric Cancer Clinical Trials

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Start date: December 1, 2022
Phase: Phase 4
Study type: Interventional

This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.

NCT ID: NCT05728424 Recruiting - Clinical trials for Helicobacter Pylori Infection

One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL

Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

1. To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. 2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

NCT ID: NCT05726734 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Start date: February 6, 2023
Phase: Phase 4
Study type: Interventional

Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

NCT ID: NCT05718609 Recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection

Start date: March 1, 2023
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the efficacy and safety of 14-day quadruple therapy based on fecal molecular antimicrobial susceptibility tests for the first-line eradication of H. pylori infection, thus, providing more evidence to inform the value of fecal antimicrobial susceptibility tests in the first-line treatment of H. pylori infection.

NCT ID: NCT05701683 Completed - Clinical trials for Helicobacter Pylori Infection

IMPROVEMENT in ERADICATION of H-PYLORI INFECTION

Start date: November 15, 2019
Phase: Phase 4
Study type: Interventional

Efficacy in terms of H pylori eradication of clarithromycin based sequential therapy with lactobacillus is better than sequential based therapy alone.

NCT ID: NCT05681689 Recruiting - Clinical trials for Helicobacter Pylori Infection

PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

Start date: December 21, 2022
Phase: Phase 3
Study type: Interventional

This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples. Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.