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Phage-microbe dynamics after sterile faecal filtrate transplantation in individuals with metabolic syndrome: a double-blind, randomised, placebo-controlled clinical trial assessing efficacy and safety

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  • Koen Wortelboer

    (Amsterdam UMC location University of Amsterdam, Experimental Vascular Medicine
    Amsterdam Cardiovascular Sciences, Diabetes & Metabolism
    Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, metabolism and nutrition)

  • Patrick A. Jonge

    (Amsterdam UMC location University of Amsterdam, Experimental Vascular Medicine
    Amsterdam Cardiovascular Sciences, Diabetes & Metabolism
    Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, metabolism and nutrition)

  • Torsten P. M. Scheithauer

    (Amsterdam UMC location University of Amsterdam, Experimental Vascular Medicine
    Amsterdam Cardiovascular Sciences, Diabetes & Metabolism
    Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, metabolism and nutrition)

  • Ilias Attaye

    (Amsterdam Cardiovascular Sciences, Diabetes & Metabolism
    Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, metabolism and nutrition
    Amsterdam UMC location University of Amsterdam, Vascular Medicine)

  • E. Marleen Kemper

    (Amsterdam UMC location University of Amsterdam, Experimental Vascular Medicine
    Amsterdam UMC location University of Amsterdam, Department of Pharmacy and Clinical Pharmacology)

  • Max Nieuwdorp

    (Amsterdam UMC location University of Amsterdam, Experimental Vascular Medicine
    Amsterdam Cardiovascular Sciences, Diabetes & Metabolism
    Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, metabolism and nutrition
    Amsterdam UMC location University of Amsterdam, Vascular Medicine)

  • Hilde Herrema

    (Amsterdam UMC location University of Amsterdam, Experimental Vascular Medicine
    Amsterdam Cardiovascular Sciences, Diabetes & Metabolism
    Amsterdam Gastroenterology Endocrinology Metabolism, Endocrinology, metabolism and nutrition)

Abstract

Bacteriophages (phages) are bacterial viruses that have been shown to shape microbial communities. Previous studies have shown that faecal virome transplantation can decrease weight gain and normalize blood glucose tolerance in diet-induced obese mice. Therefore, we performed a double-blind, randomised, placebo-controlled pilot study in which 24 individuals with metabolic syndrome were randomised to a faecal filtrate transplantation (FFT) from a lean healthy donor (n = 12) or placebo (n = 12). The primary outcome, change in glucose metabolism, and secondary outcomes, safety and longitudinal changes within the intestinal bacteriome and phageome, were assessed from baseline up to 28 days. All 24 included subjects completed the study and are included in the analyses. While the overall changes in glucose metabolism are not significantly different between both groups, the FFT is well-tolerated and without any serious adverse events. The phage virion composition is significantly altered two days after FFT as compared to placebo, which coincides with more virulent phage-microbe interactions. In conclusion, we provide evidence that gut phages can be safely administered to transiently alter the gut microbiota of recipients.

Suggested Citation

  • Koen Wortelboer & Patrick A. Jonge & Torsten P. M. Scheithauer & Ilias Attaye & E. Marleen Kemper & Max Nieuwdorp & Hilde Herrema, 2023. "Phage-microbe dynamics after sterile faecal filtrate transplantation in individuals with metabolic syndrome: a double-blind, randomised, placebo-controlled clinical trial assessing efficacy and safety," Nature Communications, Nature, vol. 14(1), pages 1-16, December.
  • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-41329-z
    DOI: 10.1038/s41467-023-41329-z
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    References listed on IDEAS

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    1. Marwan E. Majzoub & Sudarshan Paramsothy & Craig Haifer & Rohit Parthasarathy & Thomas J. Borody & Rupert W. Leong & Michael A. Kamm & Nadeem O. Kaakoush, 2024. "The phageome of patients with ulcerative colitis treated with donor fecal microbiota reveals markers associated with disease remission," Nature Communications, Nature, vol. 15(1), pages 1-14, December.

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