NCT04173208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 10, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.2 years

First QC Date

April 25, 2019

Last Update Submit

January 31, 2024

Conditions

Fecal Microbiota TransplantationCesarean Section, Affecting Fetus or NewbornIntestinal Microbiome

Keywords

TransplantCesarean sectioninflammatory responseInfant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Difference in markers of cow milk immunoglobulin Es

    At 12 months of age

  • Difference in markers of aeroallergen immunoglobulin Es

    At 24 months of age

  • Difference in tetanus and measles, mumps and rubella vaccine responses

    At 12 and 24 months of age

  • Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing

    At 6, 12 and 24 months of age

Other Outcomes (1)

  • Differences in immunoresponse to the transplant

    At 3 days and 3, 6, 12 and 24 months of age

Study Arms (2)

Fecal microbial transplant

EXPERIMENTAL

The participants of the experimental arm will receive an oral fecal microbial transplant after delivery

Other: Fecal microbial transplant

Placebo group

PLACEBO COMPARATOR

The participants of the placebo arm will receive an oral placebo after delivery

Other: Placebo

Interventions

Fecal microbial transplantOTHER

Fecal microbial transplant

Fecal microbial transplant
PlaceboOTHER

Placebo

Placebo group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-eventful pregnancy
  • planned elective CS
  • Finnish language competency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Helsinki University Hospital, Pediatric Research Center

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (1)

  • 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.

    PMID: 36175995DERIVED

Study Officials

  • Otto Helve, MD, PhD

    Children's Hospital, Helsinki University Hospital and the University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Number of enrolled mothers describes the number of mothers included for screening.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct professor

Study Record Dates

First Submitted

April 25, 2019

First Posted

November 21, 2019

Study Start

November 10, 2019

Primary Completion

January 16, 2024

Study Completion

January 31, 2025

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

FI(1)