Phase
Condition
N/ATreatment
Microbiome restoration - FVT
Placebo
Vaginal birth, untreated control
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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, gestationalhypothyroidism)
No regular use of prescription medication or any drugs that, in the research team'sopinion, may interfere with the study's results.
Willingness to abstain from giving the child products with probiotics (fermenteddairy like yogurt or A38 are allowed).
Exclusion
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 therequirements 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 cesareansection.
Infant:
Instances of major birth defects or intrauterine growth retardation (IUGR)
Infants requiring pediatric support at the time of transplant administration
Study Design
Study Description
Connect with a study center
Copsac, DBAC
Gentofte, Copenhagen 2820
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
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