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Not Yet Recruiting NCT05662514

Effect of Probiotics on Gut Microbiota During the Helicobacter Pylori Eradication

Conditions: Helicobacter Pylori Infection, Gut Microbiota

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 100
Sponsor: Qilu Hospital of Shandong University

Summary

Helicobacter pylori (H. pylori) is still infecting more than half of the population in many countries, although the prevalence is decreasing. As a main cause of chronic gastritis, peptic ulcer, and malignant gastric tumors, H. pylori places a heavy burden on developing countries and regions with high infection rate. In the last decade, the eradication rates of conventional regimens based on proton pump inhibitors (PPIs) plus antibiotics have been decreasing. Antibiotic resistance and decrease of drug compliance caused by adverse effects were the two main reasons for eradication failure. Moreover, H. pylori treatment causes dysbiosis of gut microbiota and increases the expression of antibiotic resistance gene. Therefore, eradication of H. pylori is facing a great challenge, and effective and safe methods are needed.To reduce adverse effects, improve drug compliance and increase eradication rates, certain probiotics were added to conventional regimens in several clinical studies. Probiotics were more or less shown to reduce adverse effects in the vast majority of clinical studies, but whether probiotics can improve the eradication rate of H. pylori remains controversial. Meanwhile, several studies focusing on the impact of probiotics on gut microbiota during H. pylori eradication have been published recently. Thus, we conducted a randomized, double-blind, placebo-controlled trial aiming to evaluate the effects of probiotics combining with 14-day bismuth quadruple therapy on H. pylori eradication.

Eligibility Criteria

Inclusion Criteria:Patients aged 18-70.Patients with H. pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).Patients who have did not receive H. pylori eradication treatment before.Exclusion Criteria:Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.Patients with active gastrointestinal bleeding.Patients with a history of upper gastrointestinal surgery.Patients allergic to treatment drugs.Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs which might influence gut microbiota within 3 months.Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse.Patients who are unwilling or incapable to provide informed consents.

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Source: ClinicalTrials.gov (NCT05662514). StuddyBuddy aggregates publicly available trial information.