{
  "abstract": "Introduction: Birth by caesarean section (CS) is associated with early gut microbiome perturbations and an increased risk of childhood asthma, likely reflecting long-term immune imprinting. This trial aims to restore the gut microbiota in CS-born infants through faecal microbiota transplantation (FMT) and faecal virome transplantation (FVT).\n\nMethods and analysis: RestoreGut is a double-blinded, randomised, placebo-controlled trial enrolling 60 elective CS-born and 20 vaginally born infants. CS-born infants are randomised to receive maternal FMT, FVT or placebo in the first hours after birth. FMTs and FVTs are derived from pathogen-screened maternal stool samples collected during late pregnancy, using a novel bacterial enumeration technique to standardise dosing. Infant stool samples are collected on days 1, 3 and 7, and at 1, 3, 6 and 12 months after birth and analysed for microbiome composition over time using metagenomic sequencing. The primary outcome is differences in microbiome composition between the treatment and placebo groups at the 1-week timepoint. Secondary outcomes include longitudinal differences in gut microbiome and virome composition across all subsequent timepoints during the first year of life, differences in infection incidence during the first year of life, differences in faecal metabolomic profiles and comparisons of infant microbiomes in the FMT, FVT and placebo groups to those of a vaginally born reference cohort.\n\nEthics and dissemination: This trial has received approval from the Committees on Health Research Ethics in the Capital Region of Denmark (Approval ID H-24002284). The results will be disseminated through peer-reviewed publications and the trial website, targeting both scientific audiences and the general public.\n\nTrial registration number: NCT06264219.",
  "abstract_shown": true,
  "affiliations": [
    "Copenhagen Prospective Studies on Asthma in Childhood, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark",
    "Department of Food Science, University of Copenhagen, Frederiksberg C, Denmark",
    "Department of Gynecology, Fertility and Obstetrics, Juliane Marie Center, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark",
    "Department of Infectious Diseases, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark",
    "Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark",
    "Department of Gastroenterology, Copenhagen University Hospital, Hvidovre, Denmark",
    "Department of Public Health, Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark",
    "Gastrounit, Medical Section, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark",
    "Department of Clinical Microbiology, Copenhagen University Hospital – Amager and Hvidovre, Hvidovre, Denmark",
    "Department of Neonatal and Paediatric Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark",
    "Department of Biology, University of Copenhagen, Copenhagen, Denmark"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 20,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Kaare Tranæs",
      "orcid": "0000-0002-2107-8523"
    },
    {
      "affs": [
        2
      ],
      "name": "Nina Nathan Olsén"
    },
    {
      "affs": [
        3
      ],
      "name": "Morten Helms"
    },
    {
      "affs": [
        1
      ],
      "name": "Torben Sølbeck Rasmussen"
    },
    {
      "affs": [
        0
      ],
      "name": "Julie Nyholm Kyvsgaard",
      "orcid": "0000-0002-8089-861X"
    },
    {
      "affs": [
        2,
        4
      ],
      "name": "Mona Aarenstrup Karlsen"
    },
    {
      "affs": [
        2,
        4
      ],
      "name": "Hanne Kristine Hegaard"
    },
    {
      "affs": [
        3,
        5,
        6
      ],
      "name": "Hengameh Chloé Mirsepasi-Lauridsen"
    },
    {
      "affs": [
        4,
        7,
        8
      ],
      "name": "Andreas Munk Petersen"
    },
    {
      "affs": [
        4,
        9
      ],
      "name": "Lise Aunsholt"
    },
    {
      "affs": [
        4,
        9
      ],
      "name": "Gorm Greisen"
    },
    {
      "affs": [
        1
      ],
      "name": "Dennis Sandris Nielsen"
    },
    {
      "affs": [
        10
      ],
      "name": "Søren J. Sørensen",
      "orcid": "0000-0001-6227-9906"
    },
    {
      "affs": [
        10
      ],
      "name": "Urvish Trivedi"
    },
    {
      "affs": [
        0
      ],
      "name": "Bo Chawes",
      "orcid": "0000-0001-6846-6243"
    },
    {
      "affs": [
        0
      ],
      "name": "Klaus Bønnelykke"
    },
    {
      "affs": [
        0
      ],
      "name": "Nilo Vahman"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Morten Arendt Rasmussen"
    },
    {
      "affs": [
        0,
        4
      ],
      "name": "Jonathan Thorsen"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Jakob Stokholm"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/ee7xm3n6wnc1n.bib",
  "cited_by": 0,
  "doi": "10.1136/bmjopen-2026-126018",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13735317/",
  "id": "ee7xm3n6wnc1n",
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  "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-126018",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
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  "native_subjects": [
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      "heading",
      "Paediatrics"
    ],
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      "heading",
      "Protocol"
    ],
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      "openalex",
      "1312|Gut microbiota and health"
    ]
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  "openalex": "W7225201001",
  "pdf_url": null,
  "pmcid": "PMC13735317",
  "pmid": "42971625",
  "published": "2026-11-02",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/ee7xm3n6wnc1n.ris",
  "sources": [
    {
      "first_seen": "2026-11-05T12:21:18Z",
      "native_id": "10.1136/bmjopen-2026-126018",
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      "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-126018"
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  "subjects": [
    {
      "field": "biochemistry",
      "origin": "openalex:1312|Gut microbiota and health",
      "subfield": "molecular-biology"
    }
  ],
  "title": "RestoreGut - restoration of the gut microbiome after birth by caesarean section: study protocol for a double-blinded, randomised, placebo-controlled trial",
  "title_text": "RestoreGut - restoration of the gut microbiome after birth by caesarean section: study protocol for a double-blinded, randomised, placebo-controlled trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:21:01Z",
  "url": "https://research.draconitic.com/paper/ee7xm3n6wnc1n",
  "venue": "BMJ Open",
  "versions": []
}