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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04173208
Other study ID # MT-SECFLOR
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 10, 2019
Est. completion date January 31, 2025

Study information

Verified date January 2024
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Fecal microbial transplant
Fecal microbial transplant
Placebo
Placebo

Locations

Country Name City State
Finland Children's Hospital, Helsinki University Hospital, Pediatric Research Center Helsinki Uusimaa

Sponsors (2)

Lead Sponsor Collaborator
Helsinki University Central Hospital University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

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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