Abstract
Aim: To establish whether the addition of probiotics to a globally accepted Helicobacter pylori (H. pylori)-eradication scheme may reduce the rates of side effects and increase the eradication rates. Methods. Prospective, randomized, placebo-controlled trial of patients receiving eradication therapy for H. pylori in the eight participating centers. All patients received a 10-day proton pump inhibitor containing non-bismuth quadruple therapeutic regimen for H. pylori eradication (omeprazole 20 mg, amoxycillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg all twice daily orally) and were randomized to receive either probiotics (group A) or placebo (group B). The probiotic used combined four probiotic strains, i.e., Lactobacillus Acidophilus, Lactiplantibacillus plantarum, Bifidobacterium lactis, and Saccharomyces boulardii. Results. Data were analyzed for 329 patients in group A and 335 patients in group B. Fifty six (17.0%) patients in group A and 170 (50.7%) patients in group B reported the occurrence of an H. pylori treatment-associated new symptom or the aggravation of a pre-existing symptom of any severity (p < 0.00001). H. pylori was successfully eradicated in 303 patients in group A (92.0%) and 291 patients in group B (86.8%), (p = 0.028). Conclusion: Adding probiotics to the 10-day concomitant non-bismuth quadruple H. pylori eradication regimen increases the eradication rate and decreases side effects.
Highlights
Helicobacter pylori (H. pylori) infection is considered the leading cause for the development of chronic active gastritis, gastroduodenalulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer [1]
Exclusion criteria were (1) pregnancy or lactation, (2)prior therapy for H. pylori infection, (3) therapy with antibiotics or probiotics 1 month prior of entering the study, (4) therapy with proton pump inhibitors (PPIs), H2 receptor antagonists or antacids 2 weeks prior toentering the study, (5) known allergy to any of the antibiotics used in the eradication regimen, (6) prior diagnosis of heart disease, heart failure, malignancy, thyroid disease, lung disease, or any other disease that according to the treating physician precluded the patient from entering the study, and (7) denied written informed consent
A total of 800 patients with H. pylori-positive chronic gastritis or peptic ulcer disease were screened in the participating centers during the study period
Summary
Helicobacter pylori (H. pylori) infection is considered the leading cause for the development of chronic active gastritis, gastroduodenalulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer [1]. National and International Guidelines have recommended several eradication regimens for H. pylori infection. Over the years, these regimens have been repeatedly modified to overcome the evolving resistance of. Based on the available literature, which includes well-designed clinical trials, systematic reviews, and meta-analyses, the consensus panel concluded that probiotics, as a general class, support a healthy digestive tract and a healthy immune system. This is mainly achieved by gut barrier reinforcement, neutralization of carcinogens, bile salt metabolism, vitamin synthesis, and enzymatic activity [4]. Other studies embrace opposite views on the efficiency of probiotics in assisting with the eradication [10,11]
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