The primary goal of this placebo-controlled study was determining the effect of quadruple treatment with Saccharomyces boulardii or Lactobacillus reuteri on eradication of Helicobacter pylori and side effect of the treatment.

This study was a double-blind, randomized, placebo-controlled trial. Here, eradication of helicobacter pylori was reported comparing conventional anti-H. Pylori therapy versus conventional therapy supplemented with S. boulardii and L. reuteri DSMZ 17648. A total of 156 patients were included in the current study; and patients positive for H. Pylori infection (n =156) were randomly assigned to 3 groups: 52 patients (Group P) received conventional quadruple therapy plus L. reuteri and 52 patients (Group S) received conventional quadruple therapy plus S. boulardii daily, for 2 weeks. Also, a total of 52 patients were included as control group. At the end of the treatment period, all the subjects continued to take proton pump inhibitor (PPI) alone for 14 days and then, no medication was given for 2 weeks again. Patients provided 2 fecal samples: one sample was prepared 2 weeks after PPI discontinuation, and one sample was prepared 1 month after the first test. During follow-up, gastrointestinal symptoms were assessed using an evaluation scale (Glasgow dyspepsia questionnaire (GDQ)), and adverse events were assessed at 7, 14, 21, and 28 days.

A total of 156 subjects who were confirmed to be affected with H. Pylori infection, which 60.9% of them were female and 39.1% of them were male, with a mean age of 47.76 ± 13.92 years old (age range of 16–74 years old) participated in the study. Eradication therapy was effective for 94.2 % of subjects in Group S and 92.3 % of subjects in Group P, and 86.5 % of subjects in control group with no differences between treatment arms. In the Group S, chance of developing symptoms of nausea (OR=2.74), diarrhea (OR=3.01), headache (OR=10.51), abdominal pain (OR=3.21), and anxiety (OR=3.58) was significantly lower than control group (p<0.05). But in Group P, only chance of developing headache was significantly reduced (OR=3.75, p<0.05) and no significant differences were seen in other side effects.

Findings of the study revealed that in case groups, eradication rates were improved compared to the control group, but this improvement was not statistically significant. However, in the group that received the S. boulardii probiotic as a supplement, the side effects of quadruple treatment were significantly reduced, showing that adding S. boulardii supplement to the treatment protocol of the patients affected with H. pylori infection can help to reduce the side effects of treatment.