{
  "abstract": "Background\n\nThe gut microbiota modulates peripheral immunity, which is altered in amyotrophic lateral sclerosis (ALS). Faecal microbiota transplantation (FMT) may exert immunological effects, but its impact in ALS remains unclear.Methods\n\nFETR-ALS was a multicentre, randomised, masked, sham-controlled proof-of-concept trial conducted at four Italian ALS centres. Adults with ALS of 18 months duration or less and forced vital capacity of at least 70% predicted were randomly assigned (2:1) to receive FMT or a sham procedure (SP). The intervention consisted of two nasojejunal administrations of screened-donor faecal suspension at baseline and month 6, without antibiotic preconditioning. The primary endpoint was change in circulating Tregs among CD4⁺ T cells at 6 months. Secondary endpoints included safety, ALS Functional Rating Scale-Revised slope, respiratory and nutritional measures, survival, and exploratory biomarker profiles. Analyses followed the intention-to-treat principle.Clinicaltrials\n\ngov identifier: NCT03766321.Findings\n\nBetween 2020 and 2024, 43 individuals were screened and 42 were enrolled and randomly assigned to FMT (n = 28; mean age 56.1 years [SD 8.2]; 14 [50%] male) or SP (n = 14; 59.6 years [9.1]; eight [57%] male). Overall, 29 participants completed the second procedure and 6-month follow-up, and Treg measurements were available for 28. The primary outcome was not met: at 6 months, 8/18 (44%) participant receiving FMT versus 2/10 (20%) receiving SP achieved a ≥20% increase in circulating Tregs (odds ratio [OR] 3.20, 95% CI 0.59-25.36; p = 0.21). Mean Treg increase was 2.36 percentage points higher with FMT (95% CI 0.19-4.55; p = 0.04). ALSFRS-R declined by -1.07 points/month in the SP group and -0.76 points/month in the FMT group, with a between-group difference in monthly decline of 0.31 points/month favouring FMT (95% CI 0.11-0.51; p = 0.002). Conversely, at month 6, the MRC score was lower in the FMT group than in the SP group (0.75 versus 0.89; mean difference -0.13, 95% CI -0.26 to 0.00; p = 0.042). FMT was associated with 32 adverse events (12.5% severe) versus 14 (28.6% severe) in SP, mostly gastrointestinal or infectious.Interpretation\n\nIn this exploratory trial, FMT was not associated with major safety concerns. Although the primary endpoint was not met, FMT was associated with a modest increase in circulating Tregs.Funding\n\nItalian Ministry of Health.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 74,
  "authors": [
    {
      "name": "Elisabetta Zucchi"
    },
    {
      "name": "Elena Niccolai",
      "orcid": "0000-0002-9205-8079"
    },
    {
      "name": "Flavio De Maio"
    },
    {
      "name": "Riccardo Cuoghi Costantini",
      "orcid": "0000-0002-9116-5198"
    },
    {
      "name": "Gianluca Quaranta"
    },
    {
      "name": "Alessandra Guarnaccia"
    },
    {
      "name": "Stefano Bibbò"
    },
    {
      "name": "Ilaria Martinelli"
    },
    {
      "name": "Giulia Gianferrari",
      "orcid": "0000-0002-4260-0915"
    },
    {
      "name": "Cecilia Simonini",
      "orcid": "0000-0001-5456-2365"
    },
    {
      "name": "Giulia Nannini"
    },
    {
      "name": "Matteo Lulli"
    },
    {
      "name": "Simone Baldi",
      "orcid": "0000-0002-5151-2618"
    },
    {
      "name": "Gianluca Bartolucci"
    },
    {
      "name": "Roberto Vicini",
      "orcid": "0000-0002-1799-6567"
    },
    {
      "name": "Margherita Capasso"
    },
    {
      "name": "Giulia Bisogni"
    },
    {
      "name": "Amelia Conte"
    },
    {
      "name": "Paola Brunori"
    },
    {
      "name": "Giovanni Cammarota"
    },
    {
      "name": "Sabrina Paganoni"
    },
    {
      "name": "Roberto D'Amico"
    },
    {
      "name": "Amedeo Amedei"
    },
    {
      "name": "Luca Masucci"
    },
    {
      "name": "Jessica Mandrioli",
      "orcid": "0000-0002-9244-9782"
    },
    {
      "name": "Elisabetta Zucchi"
    },
    {
      "name": "Riccardo Cuoghi Costantini"
    },
    {
      "name": "Ilaria Martinelli"
    },
    {
      "name": "Giulia Gianferrari"
    },
    {
      "name": "Cecilia Simonini"
    },
    {
      "name": "Andrea Ghezzi"
    },
    {
      "name": "Roberta Bedin"
    },
    {
      "name": "Roberto D'Amico"
    },
    {
      "name": "Nicola Fini"
    },
    {
      "name": "Roberto Vicini"
    },
    {
      "name": "Annalisa Gessani"
    },
    {
      "name": "Francesca Prompicai"
    },
    {
      "name": "Silvia Parisi"
    },
    {
      "name": "Jessica Mandrioli"
    },
    {
      "name": "Elena Niccolai"
    },
    {
      "name": "Amedeo Amedei"
    },
    {
      "name": "Giulia Nannini"
    },
    {
      "name": "Matteo Lulli"
    },
    {
      "name": "Simone Baldi"
    },
    {
      "name": "Gianluca Bartolucci"
    },
    {
      "name": "Gianluca Quaranta"
    },
    {
      "name": "Luca Masucci"
    },
    {
      "name": "Alessandra Guarnaccia"
    },
    {
      "name": "Flavio De Maio"
    },
    {
      "name": "Giovanni Fancello"
    },
    {
      "name": "Chiara Agrillo"
    },
    {
      "name": "Vanessa Di Pietro"
    },
    {
      "name": "Desy De Lorenzis"
    },
    {
      "name": "Roberto Rosato"
    },
    {
      "name": "Francesca Romana Monzo"
    },
    {
      "name": "Giovanni Cammarota"
    },
    {
      "name": "Stefano Bibbò"
    },
    {
      "name": "Irene Venturini"
    },
    {
      "name": "Debora Rondinella"
    },
    {
      "name": "Nausicaa Antonini"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/2j89new9xywd1.bib",
  "cited_by": 0,
  "doi": "10.1016/j.ebiom.2026.106509",
  "fulltext_url": "https://europepmc.org/articles/PMC13676721",
  "id": "2j89new9xywd1",
  "issns": [
    "2352-3964"
  ],
  "landing_url": "https://europepmc.org/article/MED/42849176",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "1312|Gut microbiota and health"
    ]
  ],
  "openalex": "W7220969397",
  "pdf_url": "https://europepmc.org/articles/PMC13676721?pdf=render",
  "pmcid": "PMC13676721",
  "pmid": "42849176",
  "published": "2026-10-08",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/2j89new9xywd1.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:18:02Z",
      "native_id": "MED:42849176",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42849176"
    },
    {
      "first_seen": "2026-10-30T12:19:49Z",
      "native_id": "10.1016/j.ebiom.2026.106509",
      "source": "crossref",
      "url": "https://linkinghub.elsevier.com/retrieve/pii/S2352396426003932"
    }
  ],
  "subjects": [
    {
      "field": "biochemistry",
      "origin": "openalex:1312|Gut microbiota and health",
      "subfield": "molecular-biology"
    }
  ],
  "title": "Immune effects of faecal microbiota transplantation in amyotrophic lateral sclerosis: a pilot multicentre, randomised, masked, sham-controlled, proof-of concept trial.",
  "title_text": "Immune effects of faecal microbiota transplantation in amyotrophic lateral sclerosis: a pilot multicentre, randomised, masked, sham-controlled, proof-of concept trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:49Z",
  "url": "https://research.draconitic.com/paper/2j89new9xywd1",
  "venue": "EBioMedicine",
  "versions": []
}