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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal microbial transplant | Experimental | The participants of the experimental arm will receive an oral fecal microbial transplant after delivery |
|
| Placebo group | Placebo Comparator | The participants of the placebo arm will receive an oral placebo after delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbial transplant | Other | Fecal microbial transplant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Difference in markers of aeroallergen immunoglobulin Es |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Mother:
Newborn:
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Otto Helve, MD, PhD | Children's Hospital, Helsinki University Hospital and the University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Helsinki University Hospital, Pediatric Research Center | Helsinki | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36175995 | Derived | Carpen N, Brodin P, de Vos WM, Salonen A, Kolho KL, Andersson S, Helve O. Transplantation of maternal intestinal flora to the newborn after elective cesarean section (SECFLOR): study protocol for a double blinded randomized controlled trial. BMC Pediatr. 2022 Sep 29;22(1):565. doi: 10.1186/s12887-022-03609-3. |
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Number of enrolled mothers describes the number of mothers included for screening.
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| Placebo |
| Other |
Placebo |
|
The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.
| At 24 months of age |
| 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 |
| 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 |