Helicobacter Pylori Infection Clinical Trial
Official title:
Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori
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.
Helicobacter pylori colonizes the stomach of about half of the world's population, including about 20-30% of adults in Germany. In some cases, this colonization can lead to chronic inflammation of the gastric mucosa, which can lead to various serious diseases such as ulcer disease and gastric cancer. It has been reported several times in the literature that Helicobacter pylori infection negatively affects the human intestinal flora and can lead to microbial imbalance (dysbiosis). Recent studies, mostly from mouse models, reveal new roles and interactions of the microbiome: host immune response may influence bacterial activity; bacterial metabolites may determine microbiome functions. Differences in the microbiome were also found between Helicobacter pylori-infected patients and were associated with treatment success. On the other hand, beneficial microbial symbiosis may prevent intestinal inflammation. The reasons for these differences in the microbiome of Helicobacter pylori-infected patients, which may also contribute to treatment failure, remain to be investigated. Therefore, this project aims to investigate how Helicobacter pylori affects the bacteria and fungi of the human gastrointestinal microbiome and how the suspected microbial imbalance may influence treatment success. In this project, The investigators aim to answer the question of how these newly discovered mechanisms alter the course of human H. pylori infection. The investigators will analyze H. pylori itself in colonized patients and asymptomatic individuals (whole genome sequencing), determine the immune response of the carrier (RNA expression in lymphocytes), and composition of the gut microbiome (DNA sequencing) and activity (RNA expression in the bacteria/fungi and identification of metabolites). Using bioinformatics approaches, particularly machine learning, The investigators will determine the parameters that predict disease progression and eradication success. The results will provide important decision support for H. pylori-infected patients. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05061732 -
Helicobacter Pylori Eradication and Follow-up
|
Phase 4 | |
| Completed |
NCT03779074 -
Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
|
Phase 3 | |
| Completed |
NCT06076681 -
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05329636 -
Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05065138 -
Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists
|
N/A | |
| Completed |
NCT05049902 -
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
|
Phase 4 | |
| Not yet recruiting |
NCT06200779 -
Tailored vs. Empirical Helicobacter Pylori Infection Treatment
|
Phase 4 | |
| Not yet recruiting |
NCT06037122 -
Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
|
||
| Completed |
NCT04617613 -
Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait
|
Phase 4 | |
| Completed |
NCT02873247 -
Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
|
||
| Withdrawn |
NCT02552641 -
Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
|
Phase 4 | |
| Completed |
NCT02557932 -
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
|
Phase 3 | |
| Recruiting |
NCT02249546 -
Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
|
Phase 4 | |
| Completed |
NCT01933659 -
Anti-H. Pylori Effect of Deep See Water
|
Phase 3 | |
| Unknown status |
NCT01464060 -
14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication
|
Phase 4 | |
| Completed |
NCT00841490 -
Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
|
N/A | |
| Recruiting |
NCT05728424 -
One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL
|
Phase 3 | |
| Recruiting |
NCT05549115 -
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
|
N/A | |
| Recruiting |
NCT05997433 -
Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)
|
N/A | |
| Completed |
NCT04708405 -
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
|