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Clinical Trials in Denmark / NCT06264219
Recruiting Phase 1

Restoration of the Gut Microbiome After Cesarean Section

NCT06264219 · tracked via the Priya Life Science Denmark tracker
Sponsor
Jakob Stokholm
Phase
Phase 1
Started
2024-08-02
Last updated
2026-10-07

Condition(s) studied

Microbial Colonization

Investigational drug(s) / intervention(s)

Microbiome restoration - FMTMicrobiome restoration - FVTPlaceboVaginal birth, untreated control

Microbiome restoration - FMT: Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.

Microbiome restoration - FVT: Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.

Placebo: Inactive solution buffer

Vaginal birth, untreated control: No intervention. This group is for secondary outcomes comparisons.

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Gestational age \< week 38+0 days * Proficient in spoken/written Danish * Single pregnancy (no twins or triplets) * Pre-pregnancy BMI between 18.5 and 35 kg/m2 * No chronic intestinal, endocrine, cardiac, or kidney disorders * No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism) * No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results. * Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed). Exclusion Criteria: Maternal: * Use of antibiotics within one month of stool donation * Acute gastroenteritis within one month of stool donation * Use of antibiotics within one month of birth * Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk) * Positive test results for pathogens during donor material screening. * Antibiotic treatment at birth (vaginal births only) * Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section. Infant: * Instances of major birth defects or intrauterine growth retardation (IUGR) * Infants requiring pediatric support at the time of transplant administration

Primary outcome measure(s)

  • Microbial compositional differences compared with placebo-treated infants — At 1 week of age
    Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.

Trial sites (2)

FacilityCityRegionStatus
Copsac, DBAC Gentofte Municipality Copenhagen Recruiting
Rigshospitalet Copenhagen Denmark Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06264219 on ClinicalTrials.gov ↗ ← All trials in Denmark