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Restoration of the Gut Microbiome After Cesarean Section
Sponsor: Jakob Stokholm
Summary
This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.
Official title: "Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Placebo-controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-08-02
Completion Date
2027-08-30
Last Updated
2026-06-29
Healthy Volunteers
Yes
Conditions
Interventions
Microbiome restoration - FMT
Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Microbiome restoration - FVT
Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
Placebo
Inactive solution buffer
Vaginal birth, untreated control
No intervention. This group is for secondary outcomes comparisons.
Locations (2)
Copsac, DBAC
Gentofte Municipality, Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark