Fecal Microbiota Transplantation, Cesarean Section, Affecting Fetus or Newborn, Intestinal Microbiome
Conditions
Keywords
Transplant, Cesarean section, inflammatory response, Infant
Brief summary
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome.
Detailed description
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. After faecal microbiota transfer, the children are followed for 24 months for the evaluation of markers of, for example, atopy-related diseases, and changes in immunomarkers associated with the transfer.
Interventions
Fecal microbial transplant
OTHERPlacebo
Placebo
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Number of enrolled mothers describes the number of mothers included for screening.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* non-eventful pregnancy * planned elective CS * Finnish language competency
Exclusion criteria
Mother: * maternal refusal * positive findings in screening samples * maternal antibiotic treatment within 4 weeks of delivery (excluding the antibiotic given immediately prior to clamping of the umbilical cord) * travel outside European Union during 3 months prior to delivery * CS after the onset of labor (non-elective CS) Newborn: * birth below 37 weeks of gestation * Apgar score of less than 8 * disturbances of neonatal adaptation (such as transient tachypnea of the newborn) * antibiotic treatment of the newborn before discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing | At three months of age | Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in markers of cow milk immunoglobulin Es | At 12 months of age | The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group. |
| Difference in markers of aeroallergen immunoglobulin Es | At 24 months of age | The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group. |
| Difference in tetanus and measles, mumps and rubella vaccine responses | At 12 and 24 months of age | The difference in vaccine responses between the intervention group and the placebo group (as Immunoglobulin G milli-International Units/milliliter). |
| Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing | At 6, 12 and 24 months of age | Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age |
Other
| Measure | Time frame | Description |
|---|---|---|
| Differences in immunoresponse to the transplant | At 3 days and 3, 6, 12 and 24 months of age | The differences in immunomarkers between the intervention group and the placebo group (measured by performing messenger ribonucleic acid sequencing of viable peripheral blood mononuclear cells). |
Countries
Finland
Outcome results
None listed