RestoreGut - restoration of the gut microbiome after birth by caesarean section: study protocol for a double-blinded, randomised, placebo-controlled trial

@article{tranæs2026restoregut,
  title = {{RestoreGut - restoration of the gut microbiome after birth by caesarean section: study protocol for a double-blinded, randomised, placebo-controlled trial}},
  author = {Kaare Tranæs and Nina Nathan Olsén and Morten Helms and Torben Sølbeck Rasmussen and Julie Nyholm Kyvsgaard and Mona Aarenstrup Karlsen and Hanne Kristine Hegaard and Hengameh Chloé Mirsepasi-Lauridsen and Andreas Munk Petersen and Lise Aunsholt and Gorm Greisen and Dennis Sandris Nielsen and Søren J. Sørensen and Urvish Trivedi and Bo Chawes and Klaus Bønnelykke and Nilo Vahman and Morten Arendt Rasmussen and Jonathan Thorsen and Jakob Stokholm},
  journal = {BMJ Open},
  year = {2026},
  month = nov,
  doi = {10.1136/bmjopen-2026-126018},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-126018},
  note = {CC BY-NC 4.0},
}

TY  - JOUR
TI  - RestoreGut - restoration of the gut microbiome after birth by caesarean section: study protocol for a double-blinded, randomised, placebo-controlled trial
AU  - Kaare Tranæs
AU  - Nina Nathan Olsén
AU  - Morten Helms
AU  - Torben Sølbeck Rasmussen
AU  - Julie Nyholm Kyvsgaard
AU  - Mona Aarenstrup Karlsen
AU  - Hanne Kristine Hegaard
AU  - Hengameh Chloé Mirsepasi-Lauridsen
AU  - Andreas Munk Petersen
AU  - Lise Aunsholt
AU  - Gorm Greisen
AU  - Dennis Sandris Nielsen
AU  - Søren J. Sørensen
AU  - Urvish Trivedi
AU  - Bo Chawes
AU  - Klaus Bønnelykke
AU  - Nilo Vahman
AU  - Morten Arendt Rasmussen
AU  - Jonathan Thorsen
AU  - Jakob Stokholm
PY  - 2026
DA  - 2026/11/02
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-126018
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-126018
AB  - 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).  Methods 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.  Ethics 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.  Trial registration number: NCT06264219.
SN  - 2044-6055
SN  - 2044-6055
ER  -