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Clinical Trial 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.


Clinical Trial Description

When a child is born vaginally, the passage through the birth canal provides the first and very important bacterial colonization. As the child ages, various environmental exposures, such as dietary changes and the presence of older siblings in the home, facilitate a natural maturation of the child's gut microbiome, providing a vast and continuous stimulation of the child's developing immune system. However, factors such as mode of delivery and intrapartum antibiotics can perturb this natural developmental process and cause long-term microbial derangements. The prevalence of cesarean section (CS) birth has increased globally in recent decades, and with it, antibiotic treatment to prevent perinatal infection. Similar patterns have occurred for the prevalence of chronic childhood disease, particularly asthma, with an estimated 300 million asthmatic cases worldwide. We hypothesize that early intervention with mother-to-infant FMT can restore a CS-perturbed microbiome to a normal microbial trajectory. We also hypothesize that seeding the virome fraction (FVT) will cause the neonate's microbiome to resemble the mother's since the transferred phages are enriched and preserved in the intestinal mucus layer, thereby providing the recipient with selective antimicrobial protection while allowing species resembling the mother's own to establish during subsequent bacterial transmission. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06264219
Study type Interventional
Source Copenhagen Studies on Asthma in Childhood
Contact Jakob Stokholm, MD, PhD
Phone +45 38677360
Email stokholm@copsac.com
Status Not yet recruiting
Phase Phase 1
Start date March 1, 2024
Completion date November 30, 2026

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