Efficacy of Pyloshot in combination with standard four-drug antimicrobial treatment for Helicobacter pylori eradication: A randomized clinical trial.

BACKGROUND AND AIM: The treatment for Helicobacter pylori is considered to be a combination of several strict regimens, with patients' dissatisfaction and poor compliance. Probiotics are effective in patients' antibiotic regimens. This study investigated the efficacy of the Pyloshot probiotic in combination with standard four-drug therapy in patients with H. pylori infection.

METHODS

This is an interventional study. The study population consisted of patients with H. pylori infection who were selected using the convenience sampling method and were randomly divided into two groups: (i) A or standard four-drug therapy (amoxicillin-clarithromycin-bismuth-pantoprazole) plus two placebo capsules (80 cases). (ii) B or Pyloshot group (standard four-drug therapy plus 2 Pyloshot probiotic capsules) (90 cases). Patients were followed up for 1 month after treatment completion. Eradication of H. pylori was also assessed using the stool antigen test. Data were analyzed using SPSS (v.26) statistical software.

RESULTS

Based on the results from the present study, the number of negative stool antigen tests in group A was less than that in group B, and no statistically significant relationship was found between H. pylori eradication (based on stool antigen test) and the studied groups (P = 0.20). There was a statistically significant relationship between vomiting (P = 0.03), diarrhea (P = 0.04), constipation (P = 0.01), and headache (P = 0.04); vomiting and constipation were most frequent in the control group.

CONCLUSION

Based on the results of the present study, there was no significant difference between the effectiveness of treatment with Pyloshot probiotic and the standard four-drug therapy in patients with H. pylori infection. However, the incidence of side effects was lower in the group treated with Pyloshot.