NCT06264219 Restoration of the Gut Microbiome After Cesarean Section
| NCT ID | NCT06264219 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jakob Stokholm |
| Condition | Microbial Colonization |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-08-02 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-08-02 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Klaus Bønnelykke, MD, PhD
STUDY CHAIR
Head of COPSAC
Frequently Asked Questions
Who can join the NCT06264219 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Microbial Colonization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06264219 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06264219 currently recruiting?
Yes, NCT06264219 is actively recruiting participants. Contact the research team at stokholm@copsac.com for enrollment information.
Where is the NCT06264219 trial being conducted?
This trial is being conducted at Gentofte Municipality, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT06264219 clinical trial?
NCT06264219 is sponsored by Jakob Stokholm. The principal investigator is Klaus Bønnelykke, MD, PhD at Head of COPSAC. The trial plans to enroll 80 participants.