Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study (MT-SECFLOR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fecal Microbiota Transplantation; Cesarean Section, Affecting Fetus or Newborn; Intestinal Microbiome
• Intervention / Treatment: Other: Placebo; Other: Fecal microbial transplant

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Children's Hospital, Helsinki University Hospital, Pediatric Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal microbial transplant; The participants of the experimental arm will receive an oral fecal microbial transplant after delivery	Other: Fecal microbial transplant; Fecal microbial transplant
Placebo Comparator: Placebo group; The participants of the placebo arm will receive an oral placebo after delivery	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki
• Investigators: Principal Investigator: Otto Helve, MD, PhD, Children's Hospital, Helsinki University Hospital and the University of Helsinki

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2019
• Primary Completion (Actual): January 16, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cesarean section; Infant; Transplant; inflammatory response
• Other Study ID Numbers: MT-SECFLOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No