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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173208
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Otto Helve, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Fecal Microbiota Transplantation Cesarean Section, Affecting Fetus or Newborn Intestinal Microbiome Other: Fecal microbial transplant Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
Actual Study Start Date : November 10, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing [ Time Frame: At three months of age ]
    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


Secondary Outcome Measures :
  1. Difference in markers of cow milk immunoglobulin Es [ Time Frame: At 12 months of age ]
    The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.

  2. Difference in markers of aeroallergen immunoglobulin Es [ Time Frame: At 24 months of age ]
    The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.

  3. Difference in tetanus and measles, mumps and rubella vaccine responses [ Time Frame: At 12 and 24 months of age ]
    The difference in vaccine responses between the intervention group and the placebo group (as Immunoglobulin G milli-International Units/milliliter).

  4. Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing [ Time Frame: At 6, 12 and 24 months of age ]
    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


Other Outcome Measures:
  1. Differences in immunoresponse to the transplant [ Time Frame: At 3 days and 3, 6, 12 and 24 months of age ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173208


Contacts
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Contact: Otto Helve, MD, PhD 35894711 Otto.helve@helsinki.fi

Locations
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Finland
Children's Hospital, Helsinki University Hospital, Pediatric Research Center Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Otto Helve, Adj. prof    +358505824426    otto.helve@helsinki.fi   
Contact: Sture Andersson, Prof    +35894711    sture.andersson@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
University of Helsinki
Investigators
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Principal Investigator: Otto Helve, MD, PhD Children's Hospital, Helsinki University Hospital and the University of Helsinki
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Responsible Party: Otto Helve, Adjunct professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04173208    
Other Study ID Numbers: MT-SECFLOR
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otto Helve, Helsinki University Central Hospital:
Transplant
Cesarean section
inflammatory response
Infant