Efficacy of bismuth quadruple therapy with bacillus clausii UBBC-07 and zinc carnosine for helicobacter pylori eradication: a double blind, parallel arm, randomized controlled trial

Standard regimens for H. pylori infection typically involve triple or quadruple therapy. However, rising antibiotic resistance, adverse effects, and patient non-compliance significantly limit the success rates of these regimens. Probiotics have emerged as a promising adjunct or alternative strategy for H. pylori management. Among the wide strains of probiotics, Bacillus clausii has been shown to have a promising effect in reducing the side effects of H. pylori treatment, as previously studied . In another meta-analysis published in 2014, it is reported that probiotics formulated with specific Bacillus clausii strains are known to be more effective in eradicating H. pylori infection in patients. There are only a few studies on zinc carnosine-based modified bismuth quadruple therapy in H. pylori eradication, and no study has been reported in India yet. As an effective treatment for H. pylori infection, a probiotic formulated with zinc carnosine could be a significant factor in eradicating H. pylori in view of the very high antibiotic resistance reported from India to all first-line antibiotics. We hypothesize that administering probiotics during H. pylori eradication, based on limited available data, may mitigate adverse effects associated with the medication while simultaneously enhancing the eradication rate and compliance with the treatment. Further, safety data suggests it to be safe. Therefore, we aim to plan a randomized controlled trial to evaluate the role of Bacillus clausii UBBC-07 formulated with zinc carnosine in H. pylori eradication.