Actively Recruiting
Restoration of the Gut Microbiome After Cesarean Section
Led by Professor Klaus Bønnelykke · Updated on 2024-09-20
80
Participants Needed
2
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Restoration of the Gut Microbiome After Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age less than 38 weeks and 0 days
- Proficient in spoken and 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 such as gestational diabetes, preeclampsia, or gestational hypothyroidism
- No regular use of prescription medications or drugs interfering with study results
- Willingness to abstain from giving the child probiotic products (fermented dairy like yogurt or A38 allowed)
You will not qualify if you...
- Maternal use of antibiotics within one month of stool donation
- Maternal acute gastroenteritis within one month of stool donation
- Maternal use of antibiotics within one month of birth
- Recent travel abroad violating blood donation timing requirements
- Positive pathogen test during donor material screening
- Antibiotic treatment at birth for vaginal births only
- Spontaneous labor or emergency cesarean before scheduled cesarean
- Infant major birth defects or intrauterine growth retardation (IUGR)
- Infant requiring pediatric support at transplant administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Copsac, DBAC
Gentofte Municipality, Copenhagen, Denmark, 2820
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Not Yet Recruiting
Research Team
J
Jakob Stokholm, MD, PhD
CONTACT
K
Kaare D. Tranæs, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here