The Efficacy of Paraprobiotic, Probiotic, and Mineral Supplementation on the Eradication Rate of Helicobacter pylori in Patients with Dyspepsia: A Randomized Clinical Trial

Abstract

Background. Helicobacter pylori (H. pylori) eradication regimens have been a concern, all along. Our study is aimed at assessing the effect of para- and probiotics plus minerals (Pyloshot) on H. pylori eradication rate. Methods. In this open-label randomized trial, 69 eligible adult patients with naïve H. pylori infection-related dyspepsia were randomly assigned into the group A, who received esomeprazole 40 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID, and group B with the same regimen plus one Pyloshot capsule BID for 10 days. Demographics and dyspepsia symptom severity scores (SSS), number needed to treat (NNT), dyspepsia SSS, and drug adverse effects were recorded at baseline and the end of treatment. H. pylori eradication was confirmed via 14C UBT eight weeks later. Results. Sixty-six patients completed the study. The intention-to-treat (ITT) and per-protocol (PP) eradication rates were slightly better in group B (85.2% vs. 80%, $p=0.562$, and 87.8% vs. 84.8%, $p=0.720$, respectively). Adverse effects were significantly lower in group B (20.6% vs. 54.3%; $p=0.004$). No significant differences in dyspepsia symptom improvement rates ($p=0.255$) and mean difference of SSS ($p=0.231$) were found between treatment groups. NNT for overall dyspepsia and epigastric pain syndrome (EPS) was 11 and 5 at the end of treatment, respectively. Conclusion. Adding Pyloshot to the H. pylori regimen could slightly improve the eradication rate and SSS of dyspepsia. NNT was considerably better among EPS patients. Adverse effects were significantly decreased by this regimen. Further trials with larger sample sizes should be thought out. This trial is registered with IRCT20141201020178N10.