Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study

Fecal Microbiota Transplantation Clinical Trial

— MT-SECFLOR  

Official title:

Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04173208
• Other study ID #: MT-SECFLOR
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cesarean Section, Affecting Fetus or Newborn
• Fecal Microbiota Transplantation
• Intestinal Microbiome

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