NCT06264219View on ClinicalTrials.gov

Restoration of the Gut Microbiome After Cesarean Section

PHASE1RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 2, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Microbial Colonization
Interventions
BIOLOGICAL

Microbiome restoration - FMT

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

BIOLOGICAL

Microbiome restoration - FVT

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

BIOLOGICAL

Placebo

Inactive solution buffer

OTHER

Vaginal birth, untreated control

No intervention. This group is for secondary outcomes comparisons.

Trial Locations (2)

2100

NOT_YET_RECRUITING

Rigshospitalet, Copenhagen

2820

RECRUITING

Copsac, DBAC, Gentofte Municipality

All Listed Sponsors
lead

Professor Klaus Bønnelykke

OTHER