RecruitingPhase 1NCT06264219

Restoration of the Gut Microbiome After Cesarean Section

"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Placebo-controlled Trial

Sponsor

Jakob Stokholm

Enrollment

80 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Microbial Colonization

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Microbiome restoration - FMT, a biological treatment called Microbiome restoration - FVT, and others for people with microbial colonization. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMicrobiome restoration - FMT

Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.

BIOLOGICALMicrobiome restoration - FVT

Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.

BIOLOGICALPlacebo

Inactive solution buffer

OTHERVaginal birth, untreated control

No intervention. This group is for secondary outcomes comparisons.

Locations(2)

Copsac, DBAC

Gentofte Municipality, Copenhagen, Denmark

Rigshospitalet

Copenhagen, Denmark

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NCT06264219

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