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NCT06264219

Restoration of the Gut Microbiome After Cesarean Section

Restoration of the Gut Microbiome After Cesarean Section (RestoreGut) - A Double-blinded Randomized Controlled Feasibility Trial
Professor Klaus Bønnelykke·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
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Study focus
Disease/Condition
Microbial Colonization
Drug/Device/Intervention
Microbiome restoration - FMT
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Professor Klaus Bønnelykke
Funder
Copenhagen Studies on Asthma in Childhood
Location
Gentofte,Copenhagen, Denmark
Timeline & enrollment
Phase
Phase 1
Start date
Mar 01, 2024
End date
Nov 30, 2026
Enrollment
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 siteOther bacterial infections of unspecified siteBacterial, viral and other infectious agentsCholeraOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06264219
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.