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• Journal article
  Hvas CL, Keller J, Baunwall SMD, Edwards LA, Ianiro G, Kupcinskas J, Link A, Mullish BH, Satokari R, Sokol H, Terveer E, Vehreshild MJGet al., 2023,
  , Microbiota in Health and Disease, Vol: 5, ISSN: 2704-8845

  Faecal microbiota transplantation (FMT) has evolved from an anecdotally reported last resort for the critically ill to a well-established first-line treatment for patients with recurrent Clostridioides difficile infection (CDI), supported by grade 1a evidence. Given our improved understanding of the intestinal microbiota and how it impacts human health, FMT is now being explored for a range of emerging indications beyond CDI. In light of the rapid emergence of FMT as a novel treatment strategy in medicine, a need for international harmonisation has arisen. Addressing this need, the recently published 5th edition of the Guide to the quality and safety of tissues and cells for human application, issued by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM), harbours complete descriptions of the collection, procurement and application of donor faeces as a substance of human origin (SoHO). The proposed revision of the Blood Tissue and Cell Regulation of the European Union (EU) incorporates stool for FMT as a SoHO. This revised regulation will provide a regulatory framework for the future development of donor-derived microbiome therapies. To implement and underpin the safety and quality requirements for FMT in this newly designed legal context, and to facilitate clinical use, collaboration and research, we established the European Academic FMT Network (EurFMT network). The European FMT Registry plays a pivotal role within this network, facilitating its clinical activities and monitoring safety. In this document, we summarise the basis for using donor faeces-derived microbiome therapies as well as the aim and main scope for the EurFMT network.

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• Journal article
  Kragsnaes MS, Miguens Blanco J, Mullish BH, Contreras Serrano JI, Kjeldsen J, Horn HC, Pedersen JK, Munk HL, Nilsson AC, Salam A, Lewis MR, Chekmeneva E, Kristiansen K, Marchesi JR, Ellingsen Tet al., 2023,
  , ACR Open Rheumatology, Vol: 5, Pages: 583-593, ISSN: 2578-5745

  ObjectiveWe investigated intestinal permeability and fecal, plasma, and urine metabolomic profiles in methotrexate-treated active psoriatic arthritis (PsA) and how this related to clinical response following one sham or fecal microbiota transplantation (FMT).MethodsThis exploratory study is based on the FLORA trial cohort, in which 31 patients with moderate-to-high peripheral PsA disease activity, despite at least 3 months of methotrexate-treatment, were included in a 26-week, double-blind, 1:1 randomized, sham-controlled trial. Participants were randomly allocated to receive either one healthy donor FMT (n = 15) or sham (n = 16) via gastroscopy. The primary trial end point was the proportion of treatment failures through 26 weeks. We performed a lactulose-to-mannitol ratio (LMR) test at baseline (n = 31) and at week 26 (n = 26) to assess small intestinal permeability. Metabolomic profiles in fecal, plasma, and urine samples collected at baseline, weeks 4, 12, and 26 were measured using 1H Nuclear Magnetic Resonance.ResultsTrial failures (n = 7) had significantly higher LMR compared with responders (n = 19) at week 26 (0.027 [0.017-0.33]) vs. 0.012 [0-0.064], P = 0.013), indicating increased intestinal permeability. Multivariate analysis revealed a significant model for responders (n = 19) versus failures (n = 12) at all time points based on their fecal (P < 0.0001) and plasma (P = 0.005) metabolomic profiles, whereas urine metabolomic profiles did not differ between groups (P = 1). Fecal N-acetyl glycoprotein GlycA correlated with Health Assessment Questionnaire Disability Index (coefficient = 0.50; P = 0.03) and fecal propionate correlated with American College of Rheumatology 20 response at week 26 (coefficient = 27, P = 0.02).ConclusionIntestinal permeability and fecal and plasma metabolomic profiles of patients with PsA were associated with the primary clinical trial end point, failure versus responder.

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• Journal article
  Yip AYG, King OG, Omelchenko O, Kurkimat S, Horrocks V, Mostyn P, Danckert N, Ghani R, Satta G, Jauneikaite E, Davies FJ, Clarke TB, Mullish BH, Marchesi JR, McDonald JAKet al., 2023,
  , NATURE COMMUNICATIONS, Vol: 14
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  • Citations: 39
• Journal article
  Routy B, Lenehan JG, Miller WH, Jamal R, Messaoudene M, Daisley BA, Hes C, Al KF, Martinez-Gili L, Punčochář M, Ernst S, Logan D, Belanger K, Esfahani K, Richard C, Ninkov M, Piccinno G, Armanini F, Pinto F, Krishnamoorthy M, Figueredo R, Thebault P, Takis P, Magrill J, Ramsay L, Derosa L, Marchesi JR, Parvathy SN, Elkrief A, Watson IR, Lapointe R, Segata N, Haeryfar SMM, Mullish BH, Silverman MS, Burton JP, Maleki Vareki Set al., 2023,
  , Nature Medicine, Vol: 29, Pages: 2121-2132, ISSN: 1078-8956

  Fecal microbiota transplantation (FMT) represents a potential strategy to overcome resistance to immune checkpoint inhibitors in patients with refractory melanoma; however, the role of FMT in first-line treatment settings has not been evaluated. We conducted a multicenter phase I trial combining healthy donor FMT with the PD-1 inhibitors nivolumab or pembrolizumab in 20 previously untreated patients with advanced melanoma. The primary end point was safety. No grade 3 adverse events were reported from FMT alone. Five patients (25%) experienced grade 3 immune-related adverse events from combination therapy. Key secondary end points were objective response rate, changes in gut microbiome composition and systemic immune and metabolomics analyses. The objective response rate was 65% (13 of 20), including four (20%) complete responses. Longitudinal microbiome profiling revealed that all patients engrafted strains from their respective donors; however, the acquired similarity between donor and patient microbiomes only increased over time in responders. Responders experienced an enrichment of immunogenic and a loss of deleterious bacteria following FMT. Avatar mouse models confirmed the role of healthy donor feces in increasing anti-PD-1 efficacy. Our results show that FMT from healthy donors is safe in the first-line setting and warrants further investigation in combination with immune checkpoint inhibitors. ClinicalTrials.gov identifier NCT03772899.

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• Conference paper
  Forlano R, Martinez-Gili L, Blanco JM, Skinner C, Thursz M, Marchesi Jet al., 2023,
  , EASL Congress 2023, Publisher: Elsevier, Pages: S601-S602, ISSN: 0168-8278
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• Conference paper
  Kragsnaes MS, Blanco JM, Mullish B, Contreras-Serrano JI, Horn HC, Munk H, Pedersen JK, Nilsson AC, Kristiansen K, Kjeldsen J, Marchesi J, Ellingsen Tet al., 2023,
  , European Congress of Rheumatology (EULAR), Publisher: BMJ PUBLISHING GROUP, Pages: 467-468, ISSN: 0003-4967
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• Journal article
  Churchward MA, Michaud ER, Mullish BH, Miguens Blanco J, Garcia Perez I, Marchesi JR, Xu H, Kao D, Todd KGet al., 2023,
  , Heliyon, Vol: 9, Pages: e16908-e16908, ISSN: 2405-8440
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• Conference paper
  Habboub N, Mullish BH, Moore C, Lanoria M, Challis B, Forlano R, Thursz M, Dumas M-E, Manousou Pet al., 2023,

  Investigating the correlation of a poly-metabolic risk score to clinical features in non-alcoholic fatty liver disease patients throughout a faecal microbiota transplant clinical trial

  , Publisher: ELSEVIER, Pages: S344-S345, ISSN: 0168-8278
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• Conference paper
  Edwards LA, Woodhouse C, Lee S, Mullish BH, Portlock T, Meoli L, Kronsten V, Marchesi J, Zamalloa A, Tranah T, Patel V, Shoaie S, Goldenberg S, Shawcross DLet al., 2023,

  Faecal microbiota transplant restores gut barrier function and augments ammonia metabolism in patients with advanced cirrhosis: a randomised single-blind placebo-controlled trial

  , Publisher: ELSEVIER, Pages: S7-S7, ISSN: 0168-8278
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  • Citations: 3
• Conference paper
  Mullish BH, Danckert NP, Patel R, Irwin SL, Dimitriadis S, Murray SM, Forlano R, Roberts L, Blanco JM, Faustini S, Richter AG, Powell N, Thursz MR, Manousou P, Barnes E, Marchesi J, Marjot T, Alexander JLet al., 2023,
  , Publisher: Elsevier BV, ISSN: 0016-5085
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