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

Helsinki University Central Hospital (HUCH)

Status: Active, not recruiting

Conditions: Cesarean Section, Affecting Fetus or Newborn; Intestinal Microbiome; Fecal Microbiota Transplantation

Treatments: Other: Placebo; Other: Fecal microbial transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT04173208

MT-SECFLOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Fecal microbial transplant

Experimental group

Description:

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

Treatment:

Other: Fecal microbial transplant

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo