Clinical trial NCT04173208: Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
Official title: Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fecal Microbiota Transplantation
Cesarean Section, Affecting Fetus or Newborn
Intestinal Microbiome
Keywords: Transplant
Cesarean section
inflammatory response
Infant
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2019-11-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Number of enrolled mothers describes the number of mothers included for screening.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
timeFrame: At three months of age
Secondary outcomes:
measure: Difference in markers of cow milk immunoglobulin Es
timeFrame: At 12 months of age
measure: Difference in markers of aeroallergen immunoglobulin Es
timeFrame: At 24 months of age
measure: Difference in tetanus and measles, mumps and rubella vaccine responses
timeFrame: At 12 and 24 months of age
measure: Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
timeFrame: At 6, 12 and 24 months of age
Other outcomes:
measure: Differences in immunoresponse to the transplant
timeFrame: At 3 days and 3, 6, 12 and 24 months of age
Locations:
city: Helsinki
country: Finland
facility: Children's Hospital, Helsinki University Hospital, Pediatric Research Center
state: Uusimaa
Study officials:
affiliation: Children's Hospital, Helsinki University Hospital and the University of Helsinki
name: Otto Helve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.