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

Not Applicable

Active, not recruiting

• Conditions: Cesarean Section, Affecting Fetus or Newborn; Fecal Microbiota Transplantation; Intestinal Microbiome
• Interventions: Other: Placebo; Other: Fecal microbial transplant

• Registration Number: NCT04173208
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2019-04-25
• Study Start: 2019-11-10
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Status Verified: 2024-01
• Primary Completion: 2024-01-16
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	The participants of the placebo arm will receive an oral placebo after delivery
Fecal microbial transplant	Fecal microbial transplant	The participants of the experimental arm will receive an oral fecal microbial transplant after delivery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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 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).

Trial Locations

Locations (1)

Children's Hospital, Helsinki University Hospital, Pediatric Research Center; 🇫🇮 Helsinki, Uusimaa, Finland