Cesarean Section and Intestinal Flora of the Newborn

NCT03568734 | Completed

• 1 other identifier: SECFLOR
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Mode of delivery affects gut microbiome of the infant. Infants born by caesarean section have a less heterogenous microbiome for the first weeks of life. This has been associated with an increased risk for atopy-related diseases, such as allergy and asthma. In this proof-of-principle study the investigators evaluate whether an orally delivered maternal fecal transplant to the infant during the first hours of life affects gut microbiome of the infant

Conditions

Intestinal Microbiome

Keywords

microbiome; transplant; infant; newborn

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Clinical condition, inflammatory markers

  0-3 postnatal days

Secondary Outcomes (1)

• Attachment of transplant

  1 to 12 weeks of age

Study Arms (1)

Transplant arm

EXPERIMENTAL

Fecal transplant sample given to child at delivery

Other: Fecal transplant

Interventions

Fecal transplant OTHER

At delivery, i.e. 39-40 weeks of gestation, the newborn infant is given 0.1 g maternal fecal sample (in 0.5 ml of the isotonic saline+10 % glycerol) dissolved in 10 ml of bank milk orally. The sample is given within 2 h of birth. Milk containing fecal sample (2 ml) is given as a part of a total feeding of 5-10 ml.

Transplant arm

Eligibility Criteria

• Gender Eligibility Details: Pregnant women only
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy pregnancy
• planned cesarean section delivery

You may not qualify if:

• positive GBS status
• maternal refusal
• maternal antibiotic treatment within the last 3 months
• any travel outside of European Union within the last 3 months
• multiple pregnancy and CS after the onset of labor (non-elective CS)
• Apgar score of less than 8
• disturbances of neonatal adaptation (such as transient tachypnea of the newborn)
• antibiotic treatment of the newborn before discharge

Sponsors & Collaborators

• Sture Andersson: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (1)

• Korpela K, Helve O, Kolho KL, Saisto T, Skogberg K, Dikareva E, Stefanovic V, Salonen A, Andersson S, de Vos WM. Maternal Fecal Microbiota Transplantation in Cesarean-Born Infants Rapidly Restores Normal Gut Microbial Development: A Proof-of-Concept Study. Cell. 2020 Oct 15;183(2):324-334.e5. doi: 10.1016/j.cell.2020.08.047. Epub 2020 Oct 1.

  PMID: 33007265 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Sture Andersson, Prof

  Professor of neonatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 12 mothers participating in the study (due for caesarean section) are screened for transmissible diseases. A transplant sample is gathered from the mother, processed, and given to the infant at delivery by caesarean section.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: June 26, 2018
• Study Start: October 27, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 31, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

FI (1)