Restoration of the Gut Microbiome After Cesarean Section
"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - a Double-blinded Randomized Controlled Feasibility Trial
Professor Klaus Bønnelykke
80 participants
Aug 2, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria11
- 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
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Interventions
Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
Inactive solution buffer
No intervention. This group is for secondary outcomes comparisons.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06264219