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Restoration of the Gut Microbiome After Cesarean Section - Trial NCT06264219

Access comprehensive clinical trial information for NCT06264219 through Pure Global AI's free database. This Phase 1 trial is sponsored by Professor Klaus Bønnelykke and is currently Not yet recruiting. The study focuses on Microbial Colonization. Target enrollment is 80 participants.

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NCT06264219
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov • NCT06264219
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Restoration of the Gut Microbiome After Cesarean Section
Restoration of the Gut Microbiome After Cesarean Section (RestoreGut) - A Double-blinded Randomized Controlled Feasibility Trial

Study Focus

Microbial Colonization

Microbiome restoration - FMT

Interventional

biological

Sponsor & Location

Professor Klaus Bønnelykke

Copenhagen Studies on Asthma in Childhood

Gentofte,Copenhagen, Denmark

Timeline & Enrollment

Phase 1

Mar 01, 2024

Nov 30, 2026

80 participants

Primary Outcome

Microbial development trajectory

Summary

This study aims to develop a therapy for restoring the gut microbiome in infants born via CS.
 We 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.

ICD-10 Classifications

Bacterial infection of unspecified site
Other bacterial infections of unspecified site
Bacterial, viral and other infectious agents
Cholera
Other specified bacterial intestinal infections

Data Source

ClinicalTrials.gov

NCT06264219

Non-Device Trial