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Helicobacter Pylori Infection clinical trials

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NCT ID: NCT05129176 Recruiting - Clinical trials for Helicobacter Pylori Infection

Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin

Start date: November 23, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

NCT ID: NCT05126121 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy and Safety of 14-day Concomitant Therapy for Difficult-to-Treat Helicobacter Pylori Infection

Start date: November 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of Hard-to-treat Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates

NCT ID: NCT05121025 Recruiting - Clinical trials for Helicobacter Pylori Infection

Pathogen-microbiome Interaction During Helicobacter Pylori Infection

PREDICTHP
Start date: March 11, 2022
Phase:
Study type: Observational

Helicobacter pylori affects the gut microbiome in ways that are only partially understood. In which patients H. pylori causes severe disease and in whom it merely colonizes, possibly even with beneficial effects, is not understood. The investigators are pursuing the hypothesis that changes in the gut microbiome that can be easily measured in stool have such predictive value.

NCT ID: NCT05100446 Recruiting - Gastric Cancer Clinical Trials

Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection

Start date: May 1, 2021
Phase: Early Phase 1
Study type: Interventional

Helicobacter pylori is a pathogenic bacteria transmitted from individual to individual, being scientifically recognized as an agent who causes persistent inflammatory activity on the gastric mucosa. This pathogen represents a Global Health problem, as shown in a systematic review by Hooi et al. Besides regional differences, more that half of the world population is expected to have already been infected by this bacteria. In Portugal, research studies estimate that more than 80% of the adult population has already contacted with H. pylori. H. pylori infection is associated with active chronic gastritis in every colonized patient, what may consequently lead to peptic ulcer disease, atrophic gastritis, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. For that reason, H. pylori infection is considered to be a disease, independently of the presence of gastrointestinal symptoms. Additionally, H. pylori has been classified as a confirmed carcinogen (class I) by the International Agency for Research, being responsible for carcinogenic pathways conducting to both gastric adenocarcinoma and lymphoma. This fact gains a particular relevance taking into account that gastric cancer is one of the most prevalent cancers worldwide. On other hand, more than 75% of the gastric cancers occur following H. pylori infection. Thus, H. pylori eradication constitutes an essential Public Health measurement, being inclusively considered a cost-effective method to decrease the gastric cancer burden, by promoting pre-malignant lesions regression, such as atrophic gastritis, and by delaying the disease progression in case of intestinal metaplasia or dysplasia. Maastricht V consensus is a document updated in 2016, including the major recommendations regarding H. pylori diagnosis, follow-up and treatment. It highlights the emergence of antibiotic resistances and how they must influence clinical practice, namely the choice of antibiotic regimens, as successful eradication has become less frequent with more prevalent antibiotic resistances. This is the case of clarithromycin and metronidazol, both currently recommended as first-line options by the Portuguese Society of Gastroenterology. In fact, a systematic review conducted in 2018, aiming to evaluate antibiotic resistances on the Portuguese population observed that clarithromycin, metronidazole and double resistance occurred in 42%, 25% and 20% of the individuals, respectively. Nowadays, Maastricht V guidelines recommend quadruple regimens containing bismuth, such as Pylera (r), as the first-line option in areas with significant double resistance to metronidazole and clarithromycin. Another option currently being investigated is the double therapy with amoxicillin in high doses and proton pump inhibitor. This has become a particularly attractive alternative due to its efficacy, good tolerability and significantly low resistance (<1%) among the European population. The aim of this clinical trial is to compare both regimens - pylera (r) and high-dose amoxycillin - in H. pylori eradication, regarding their efficacy, tolerability and side effects, in order to asses viable therapeutic options in a population with progressively increasing resistances to alternative regimens currently recommended.

NCT ID: NCT05097846 Recruiting - Clinical trials for Helicobacter Pylori Infection

Differences in the Eradication of Helicobacter Pylori by Different Therapies

Start date: June 17, 2021
Phase: N/A
Study type: Interventional

To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.

NCT ID: NCT05065138 Recruiting - Clinical trials for Helicobacter Pylori Infection

Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists

Start date: September 22, 2021
Phase: N/A
Study type: Interventional

The researchers recruited gastroenterologists. Physician subjects recruited Helicobacter pylori-positive patients before and after receiving standardized training on Helicobacter pylori eradication. There are no restrictions on treatment options and drugs during the trial. Compare the eradication rate, adverse reaction rate, and patient compliance before and after physician training.

NCT ID: NCT05061732 Recruiting - Clinical trials for Helicobacter Pylori Infection

Helicobacter Pylori Eradication and Follow-up

Start date: September 30, 2021
Phase: Phase 4
Study type: Interventional

This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

NCT ID: NCT05049902 Completed - Clinical trials for Helicobacter Pylori Infection

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

Start date: September 21, 2021
Phase: Phase 4
Study type: Interventional

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

NCT ID: NCT05046990 Recruiting - Clinical trials for Helicobacter Pylori Infection

Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori

MOTIVATION
Start date: December 1, 2021
Phase:
Study type: Observational

To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification. Gold standard will be mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs). Participants will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases. Secondary objectives are: - To assess whether age, sex and PPIs, have an influence on the results of RAC. - To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC. - To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence. Primary and secondary variables The primary study variable is: - Endoscopic detection of RAC. Secondary variables will be considered: - Sex - Age - PPI intake in the last two weeks - Centre - Country - Hp prevalence - Endoscopist - Type of endoscope - Significant findings (need of histological confirmation) - Atrophic gastritis - Intestinal metaplasia - Erosive gastritis - Benign gastric ulcer - Gastric adenoma - Gastric cancer

NCT ID: NCT05035186 Completed - Clinical trials for Helicobacter Pylori Infection

Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era

Start date: March 21, 2021
Phase: N/A
Study type: Interventional

Era of COVID-19 and the related panic lead to widely spread antibiotics misuse especially for azithromycin. Cross sensitivity between azithromycin and clarithromycin can impact success rates of H. pylori treatment regimens.(1) Here we aim to explore this point in Egyptian patients. Sample size Supposing the cure rate of clarithromycin-based regimen to levofloxacin based regimen is 69% versus 84.5% respectively. Using Medcalc, the minimal required sample size is 116 patients for each arm (type 1 error= 5%, type II error=20%). Each arm increased by 10% to compensate for drop-out. The sample size will be 135 for each arm. Study Arms: - Arm 1: The first group will receive (amoxicillin 1g/12 hrs, Clarithromycin 500 mg/12hrs, esomeprazole 40mg/12hrs) - Arm 2: The second group will receive (esomeprazole 40 mg/12hrs, levofloxacin 500 mg/24 hrs, and amoxicillin 1gm/12 hrs). - To confirm patient compliance, we will ask patients to bring their remaining medication and counted the rest of their pills. Patients with a compliance of <80% will be excluded from the study per protocol (PP) analysis.