High Effective of 14-Day High-Dose PPI- Bismuth-Containing Quadruple Therapy with Probiotics Supplement for Helicobacter Pylori Eradication: A Double Blinded-Randomized Placebo-Controlled Study

Abstract

Background: Helicobacter pylori (H. pylori) infection is important risk factors for chronic gastritis, peptic ulcer and<br />gastric cancer. Bismuth-containing quadruple therapy has recently been the first-line regimen recommended in many<br />European countries but has limited efficacy in ASEAN especially Thailand. This study was aim to evaluate efficacy of<br />high dose PPI Bismuth-containing quadruple therapy with probiotics supplement for H. pylori eradication. Methods:<br />In this double-blind randomized placebo-controlled study, H. pylori infected patients were randomized to receive 7-or<br />14-day high dose PPI- bismuth-containing quadruple therapy with or without probiotics supplement. Probiotic was<br />37.5 mg Lactobacillus reuteri (Biogaia®) in tablet twice daily. CYP2C19 genotyping and antibiotic susceptibility tests<br />were also done. H. pylori eradication was defined as a negative 13C-urea breath test at least 4 weeks after treatment.<br />Results: 100 subjects were enrolled (72 females, 28 males, mean age=54 years). Antibiotic resistance was 15.6% for<br />clarithromycin, 34.1% for metronidazole. CYP2C19 genotyping was performed in both group and revealed 13%, 50% and<br />37% for poor, intermediate and rapid metabolizers, respectively. Overall eradication rates of 7-day and 14-day regimens<br />with probiotic were 68% and 96%; P value=0.027. The eradication rate for all patients with poor and rapid metabolizers<br />were 100% with 14-day regimen. 14-day regimen with probiotics can provide 100% eradication with clarithromycin<br />resistance, metronidazole resistance or dual clarithromycin and metronidazole resistance group. Furthermore, the<br />incidence of nausea and vomiting, abdominal discomfort, and bitter taste were significantly lower in patients with<br />probiotics group compared with placebo (6%vs.26%, P=0.002,OR=0.126,95% CI=0.03-0.53; 4%vs.18.0%, P=0.017,<br />OR= 0.155,95% CI=0.03-0.81 and 4%vs.26%, P= 0.001,OR= 0.08, 95%CI= 0.016-0.41, respectively). Conclusions:<br />The 14-day high dose PPI- bismuth-containing quadruple therapy with probiotic can provide an excellent cure rate for<br />H. pylori infection as first line treatment irrespective of CYP2C19 and antibiotic resistance pattern. Adding probiotic<br />also significantly reduced treatment-related adverse events and improve the patients' compliance.