Fecal Microbiota Transplantation Clinical Trial
— MT-SECFLOROfficial title:
Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
Verified date | January 2024 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 16, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Children's Hospital, Helsinki University Hospital, Pediatric Research Center | Helsinki | Uusimaa |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | University of Helsinki |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Differences in immunoresponse to the transplant | 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). | At 3 days and 3, 6, 12 and 24 months of age | |
Primary | Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing | 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 | At three months of age | |
Secondary | Difference in markers of cow milk immunoglobulin Es | The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group. | At 12 months of age | |
Secondary | Difference in markers of aeroallergen immunoglobulin Es | The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group. | At 24 months of age | |
Secondary | Difference in tetanus and measles, mumps and rubella vaccine responses | The difference in vaccine responses between the intervention group and the placebo group (as Immunoglobulin G milli-International Units/milliliter). | At 12 and 24 months of age | |
Secondary | Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing | 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 | At 6, 12 and 24 months of age |
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