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Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial.

  • 2021-08
  • EBioMedicine 70
    • Ayodeji Awoyemi
    • Cristiane Mayerhofer
    • Alex S Felix
    • Johannes R Hov
    • Samuel D Moscavitch
    • Knut Tore Lappegård
    • Anders Hovland
    • Sigrun Halvorsen
    • Bente Halvorsen
    • Ida Gregersen
    • Asbjørn Svardal
    • Rolf K Berge
    • Simen H Hansen
    • Alexandra Götz
    • Kristian Holm
    • Pål Aukrust
    • Sissel Åkra
    • Ingebjørg Seljeflot
    • Svein Solheim
    • Andrea Lorenzo
    • Lars Gullestad
    • Marius Trøseid
    • Kaspar Broch

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 151
Population
patients with LVEF <40% and New York Heart Association functional class II or III, despite optimal medical therapy
Methods
multicentre, prospective randomized open label, blinded end-point trial, randomized patients to treatment with Saccharomyces boulardii, rifaximin, or standard of care only
Blinding
Open-label
Duration
three months
Funding
Mixed (industry + independent)
  • Large Human Trial

Background

The gut microbiota represents a potential treatment target in heart failure (HF) through microbial metabolites such as trimethylamine N-oxide (TMAO) and systemic inflammation. Treatment with the probiotic yeast Saccharomyces boulardii have been suggested to improve left ventricular ejection fraction (LVEF).

Methods

In a multicentre, prospective randomized open label, blinded end-point trial, we randomized patients with LVEF <40% and New York Heart Association functional class II or III, despite optimal medical therapy, to treatment (1:1:1) with the probiotic yeast Saccharomyces boulardii, the antibiotic rifaximin, or standard of care (SoC) only. The primary endpoint, the baseline-adjusted LVEF at three months, was assessed in an intention-to-treat analysis.

Findings

We enrolled a total of 151 patients. After three months' treatment, the LVEF did not differ significantly between the SoC arm and the rifaximin arm (mean difference was -1•2 percentage points; 95% CI -3•2 - 0•7; p=0•22) or between the SoC arm and the Saccharomyces boulardii arm (mean difference -0•2 percentage points; 95% CI -2•2 - 1•9; p=0•87). We observed no significant between-group differences in changes in microbiota diversity, TMAO, or C-reactive protein.

Interpretation

Three months' treatment with Saccharomyces boulardii or rifaximin on top of SoC had no significant effect on LVEF, microbiota diversity, or the measured biomarkers in our population with HF.

Funding

The trial was funded by the Norwegian Association for Public Health, the Blix foundation, Stein Erik Hagen's Foundation for Clinical Heart Research, Ada og Hagbart Waages humanitære og veldedige stiftelse, Alfasigma, and Biocodex.

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