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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Microbiome restoration - FMT
Biological/VaccinePathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Microbiome restoration - FVT
Biological/VaccineSterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
Placebo
Biological/VaccineInactive solution buffer
Vaginal birth, untreated control
Other interventionNo intervention. This group is for secondary outcomes comparisons.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: FMT (Fecal microbiota transplantation)Active comparator 1 intervention
Group B: FVT (Fecal virome transplantation)Active comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Group D: Vaginal control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Microbial compositional differences compared with placebo-treated infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Time frame
At 1 week of ageSecondary outcomes
1
Microbial compositional differences compared with placebo-treated infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Time frame
During the first year of life2
Microbial compositional resemblance to vaginally-born infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Time frame
At 1 week of age3
Microbial compositional resemblance to vaginally-born infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Time frame
During the first year of life4
Virome compositional differences compared with placebo-treated infants
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Time frame
At 1 week of ageOther outcomes
1
Stool metabolite differences compared with placebo-treated infants
Fecal metabolomic profiles, assessed with GC-MS and LC-MS or Nuclear Magnetic Resonance (NMR)
Time frame
At 1 week of age2
Stool metabolite differences compared with placebo-treated infants
Fecal metabolomic profiles, assessed with GC-MS and LC-MS or Nuclear Magnetic Resonance (NMR)
Time frame
During the first year of life3
Infection incidence rate
Differences in infection counts between treatment groups.
Time frame
During the first year of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jakob Stokholm
Lead sponsor
Copenhagen Studies on Asthma in Childhood
Sponsor institution
Source ClinicalTrials.gov