Helicobacter Pylori Eradication Therapy in Portugal

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Helicobacter pylori (H. pylori) infection remains a major public health problem, with an estimated prevalence of over 50% worldwide and 60-86% for Portugal. H. pylori is associated with significant morbidity and mortality from peptic ulcerative disease to gastric cancer, whose eradication therapy has proven to be effective in preventing these complications. Factors involved in the development of these conditions include H. pylori virulence, host genetic factors and gut microbiota. Given the increasing pattern of antibiotic resistance evidenced by this bacterium and the scarcity of available antibiotic therapy, both in Portugal and worldwide, there is not enough evidence on the best eradication strategy. Regarding the uncertainties about the potential negative impact of indiscriminate use of eradication therapy on gut microbiota, either by proton pump inhibitors or by antibiotics per se, there is an overriding need for evidence about the real impact of this therapy on oral or gut flora and possible clinical consequences in immunological, metabolic, nutritional and oncological terms.

Objectives: Comparative evaluation of the efficacy of the different quadruple therapy regimens recommended for the H. pylori eradication. Comparative evaluation of the safety profile in terms of clinical, and immunological and gut microbiota impact of the different therapies for the H. pylori eradication.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.
• Collaborator: University of Coimbra
• Treatments: Bismuth

Criteria

Inclusion Criteria:

• Gastric infection by H. pylori by histological examination of gastric biopsies or carbon 13-labeled urea breath test.

Exclusion Criteria:

• Age < 18 years;

• Pregnant, breast-feeding or women of childbearing age who do not comply with effective anticonception measures;

• History of allergy, hypersensitivity or contraindication to the use of H. pylori eradication drugs (antibiotics or proton pump inhibitors);

• History of previous gastrointestinal surgery or neoplasia;

• Previous H. pylori eradication therapies; Antibiotic or probiotic therapies in the month prior to recruitment;

• Use of proton pump inhibitors, other antacids or gastric mucosal protection agents in the 2 weeks prior to recruitment;

• Corticosteroids or immunomodulatory therapy in the month prior to recruitment;

• Immunodeficiency;

• Insulin-treated diabetes mellitus;

• Obesity (Body mass index ≥30Kg/m2);

• Use of laxative therapy in the 15 days prior to recruitment;

• Decompensated heart, liver, kidney or respiratory diseases and;

• Refusal or inability to give informed consent.