Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial

Abstract

Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects.Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion.Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery.Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication.Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828

Probiotics modulate gastrointestinal microbiota after Helicobacter pylori eradication: A multicenter randomized double-blind placebo-controlled trial

“…We observed no difference between probiotics and placebo group in eradication rate, both of which achieved up to 90% as revealed by PP analysis. Additionally, we found that probiotics combination mitigated gastrointestinal adverse events induced by eradication therapy, which is in agreement with other studies ( 10 , 12 ).…”

“…Recently, a large number of studies explored the efficacy of adjuvant probiotics therapy for patients with H. pylori infection, yet the clinical outcomes were controversial ( 3 ). While some studies reported improved eradication rate in patients given probiotics, others showed negative results ( 10 , 22 ). We observed no difference between probiotics and placebo group in eradication rate, both of which achieved up to 90% as revealed by PP analysis.…”

“…Probiotics, as live micro-organisms, are commonly used to modulate gut microbiota and ameliorate human diseases like metabolic syndrome, colitis, and antibiotic-associated diarrhea ( 9 ). A large body of studies has shown that probiotics supplementation mitigates the side effects during H. pylori eradication, although with controversial effect on improving eradication rate ( 10 , 11 ). Moreover, several randomized controlled trials have observed that probiotics supplementation help to construct a beneficial profile of gut microbiota after eradication therapy ( 12 ).…”

The efficacy and safety ofSaccharomyces boulardiiin addition to antofloxacin-based bismuth quadruple therapy forHelicobacter pylorieradication: a single-center, prospective randomized-control study

“…Recently, Yu et al proposed adding S. boulardii to quadruple therapy, which relieved H. pylori eradication - induced antibiotic-associated side effects but did not improve the eradication rate of H. pylori. 19 Based on the outcomes of current studies, S. boulardii did reduce treatment-associated side effects for H. pylori eradication, especially gastrointestinal symptoms, but whether S. boulardii could improve the eradication rate of 14-day quadruple therapy for H. pylori was still lack of adequate evidence and has to be discussed further, just as what the guidelines have mentioned. In this study, we aimed to demonstrate the efficacy and safety of S. boulardii supplementation on antofloxacin-based bismuth quadruple therapy for H. pylori eradication.…”

Saccharomyces boulardii Allows Partial Patients to Avoid Reusing Bismuth Quadruple for Helicobacter pylori Rescue Therapy: A Single-Center Randomized Controlled Study

“…Two meta-analyses have shown that the supplementation with S. boulardii in the standard triple therapy can increased the eradication rate of H. pylori and reduced the incidence of overall side effects ( Szajewska et al., 2010 ; Szajewska et al., 2015 ). However, several studies have reported that treatment with S. boulardii combined with the bismuth quadruple can reduce side effects in patients, but fails to further improve eradication rates ( Chen et al., 2018 ; Zhao et al., 2021 ; Naghibzadeh et al., 2022 ). In addition, treatment of H. pylori infection with probiotic monotherapy in children has an eradicate 29.3% of cases ( Boonyaritichaikij et al., 2009 ), While treatment with S.boulardii alone has an eradication rate of 11.8% ( Gotteland et al., 2005 ).…”