Restoration of the Gut Microbiome After Cesarean Section
ConditionMicrobial Colonization
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJakob Stokholm
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Microbiome restoration - FMT
- Microbiome restoration - FVT
- Placebo
- Vaginal birth, untreated control
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Jakob Stokholm
Lead sponsor
Copenhagen Studies on Asthma in Childhood
Sponsor institution
Source ClinicalTrials.gov