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

Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway. Electronic address: a.o.awoyemi@medisin.uio.no. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Department of Cardiology, Oslo University Hospital, Rikshospitalet, 0372 Oslo, Norway; Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway. Instituto Nacional de Cardiologia, 22240-006 Rio de Janeiro, Brazil. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway; Norwegian PSC Research Center, Department of Transplantation Medicine, Division of Surgery, Inflammation Medicine and Transplantation, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway; Section of Gastroenterology, Department of Transplantation Medicine, Division of Surgery, Inflammation Medicine and Transplantation, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway. Laboratory of Immunopharmacology, Oswaldo Cruz Institute, Fiocruz, Rio de Janeiro, 21040-900, Brazil. Division of Internal Medicine, Nordlandssykehuset, 8005 Bodø, Norway; Institute of Clinical Medicine, University of Tromsø, 9037 Tromsø, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway. Department of Clinical Science, University of Bergen, 5020 Bergen, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Norwegian PSC Research Center, Department of Transplantation Medicine, Division of Surgery, Inflammation Medicine and Transplantation, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway. Norwegian PSC Research Center, Department of Transplantation Medicine, Division of Surgery, Inflammation Medicine and Transplantation, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway; Norwegian PSC Research Center, Department of Transplantation Medicine, Division of Surgery, Inflammation Medicine and Transplantation, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, 0372 Oslo, Norway; Section of Clinical Immunology and Infectious diseases, Oslo University Hospital, Rikshospitalet, 0372 Oslo, Norway. Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway. Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway. Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway; Department of Cardiology, Oslo University Hospital Ullevål, 0424 Oslo, Norway. Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway; Department of Cardiology, Oslo University Hospital, Rikshospitalet, 0372 Oslo, Norway; KG Jebsen Center for Cardiac Research, University of Oslo, 0450 Oslo, Norway. Department of Cardiology, Oslo University Hospital, Rikshospitalet, 0372 Oslo, Norway; KG Jebsen Center for Cardiac Research, University of Oslo, 0450 Oslo, Norway.

EBioMedicine. 2021;:103511
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Abstract

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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