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Restoration of the Gut Microbiome After Cesarean Section

NCT06264219 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-20

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Professor Klaus Bønnelykke

    lead OTHER

Principal Investigators

  • Klaus Bønnelykke, MD, PhD · Head of COPSAC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2025-11-30
Completion
2026-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264219 on ClinicalTrials.gov