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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Helsinki University Central Hospital
Updated on 19 February 2022
Accepts healthy volunteers

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.

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.

Details
Condition Fecal Microbiota Transplantation, Cesarean Section, Affecting Fetus or Newborn, Intestinal Microbiome
Treatment Placebo, Fecal Microbial transplant
Clinical Study IdentifierNCT04173208
SponsorHelsinki University Central Hospital
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note