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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Professor Klaus Bønnelykke · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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. The hypothesis is that early intervention with mother-to-infant FMT can restore a CS-perturbed microbiome to a normal microbial trajectory. Another hypothesis is 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.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-02
• Primary completion: 2025-11-30
• Completion: 2026-11-30
• First posted: 2024-02-16
• Last updated: 2024-09-20

Locations

2 sites across 1 country: Denmark