dc.date.accessioned | 2021-08-25T16:29:15Z | |
dc.date.available | 2021-08-25T16:29:15Z | |
dc.date.created | 2021-08-06T15:56:33Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Awoyemi, Ayodeji Olawale Mayerhofer, Cristiane Felix, Alex S. Hov, Johannes Espolin Roksund Moscavitch, Samuel D. Lappegård, Knut Tore Hovland, Anders Halvorsen, Sigrun Halvorsen, Bente Gregersen, Ida Svardal, Asbjørn M. Berge, Rolf Kristian Hansen, Simen Hyll Götz, Alexandra Holm, Kristian Aukrust, Pål Åkra, Sissel Seljeflot, Ingebjørg Solheim, Svein Lorenzo, Andrea Gullestad, Lars Trøseid, Marius Broch, Kaspar . Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial. EBioMedicine. 2021, 70 | |
dc.identifier.uri | http://hdl.handle.net/10852/87262 | |
dc.description.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. | |
dc.language | EN | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Rifaximin or Saccharomyces boulardii in heart failure with reduced ejection fraction: Results from the randomized GutHeart trial | |
dc.type | Journal article | |
dc.creator.author | Awoyemi, Ayodeji Olawale | |
dc.creator.author | Mayerhofer, Cristiane | |
dc.creator.author | Felix, Alex S. | |
dc.creator.author | Hov, Johannes Espolin Roksund | |
dc.creator.author | Moscavitch, Samuel D. | |
dc.creator.author | Lappegård, Knut Tore | |
dc.creator.author | Hovland, Anders | |
dc.creator.author | Halvorsen, Sigrun | |
dc.creator.author | Halvorsen, Bente | |
dc.creator.author | Gregersen, Ida | |
dc.creator.author | Svardal, Asbjørn M. | |
dc.creator.author | Berge, Rolf Kristian | |
dc.creator.author | Hansen, Simen Hyll | |
dc.creator.author | Götz, Alexandra | |
dc.creator.author | Holm, Kristian | |
dc.creator.author | Aukrust, Pål | |
dc.creator.author | Åkra, Sissel | |
dc.creator.author | Seljeflot, Ingebjørg | |
dc.creator.author | Solheim, Svein | |
dc.creator.author | Lorenzo, Andrea | |
dc.creator.author | Gullestad, Lars | |
dc.creator.author | Trøseid, Marius | |
dc.creator.author | Broch, Kaspar | |
cristin.unitcode | 185,53,11,10 | |
cristin.unitname | Hjertemedisinsk avdeling | |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |
dc.identifier.cristin | 1924461 | |
dc.identifier.bibliographiccitation | info:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=EBioMedicine&rft.volume=70&rft.spage=&rft.date=2021 | |
dc.identifier.jtitle | EBioMedicine | |
dc.identifier.volume | 70 | |
dc.identifier.pagecount | 0 | |
dc.identifier.doi | https://doi.org/10.1016/j.ebiom.2021.103511 | |
dc.identifier.urn | URN:NBN:no-89891 | |
dc.type.document | Tidsskriftartikkel | |
dc.type.peerreviewed | Peer reviewed | |
dc.source.issn | 2352-3964 | |
dc.identifier.fulltext | Fulltext https://www.duo.uio.no/bitstream/handle/10852/87262/1/1-s2.0-S2352396421003042-main.pdf | |
dc.type.version | PublishedVersion | |
cristin.articleid | 103511 | |