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Cesarean Section and Intestinal Flora of the Newborn (SECFLOR)

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ClinicalTrials.gov Identifier: NCT03568734
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sture Andersson, Helsinki University Central Hospital

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

Condition or disease Intervention/treatment Phase
Intestinal Microbiome Other: Fecal transplant Not Applicable

Detailed Description:

Background

The immune system is affected by the colonizing microbiome. The gut microbiome has been associated with a multitude of inflammatory diseases, such as the development of autoimmune diseases. The association between microbiome and allergic diseases, asthma, type I diabetes and inflammatory bowel diseases have been demonstrated. Moreover, changes in gut microbiome during the first weeks of life have been associated with the development of atopy.

Already at birth, a low concentration of bacteria is present in the meconium of the vaginally delivered infant. Although the neonatal stool is not fully sterile, colonization of the intestinal tract takes place at delivery and throughout the first years of life. The gut microbiome of infants delivered vaginally (VD) and by cesarean section (CS) differs markedly from each other and this difference persists throughout the first years of life. The gut microbiome of infants born by CS have a lower total microbiota diversity and lower Th1 response than those born by VD. Infants delivered by CS been shown to be more likely to develop chronic inflammatory and allergic diseases, eg. inflammatory bowel disease, and systemic connective disorders, and asthma than those delivered vaginally.

Partial restoration of the microbiota of CS-infants was seen when introduced with vaginal microbial transfer. However, the vaginal microbiome is very limited to mainly Lactobacillus spp. and does not contain the microbes that are abundant in the gut microbiota of the mother. Fecal transplantation, or intestinal microbiota transfer, is used to treat chronic infections of Clostridium difficile. However, fecal transplantation has not been used to compensate for the low diversity of CS infants. In this pilot, proof-of-concept and safety evaluation study, the researchers aim to assess the feasibility of fecal transplantation after birth in infants delivered by CS.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cesarean Section and Intestinal Flora of the Newborn
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transplant arm
Fecal transplant sample given to child at delivery
Other: Fecal transplant
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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 0-3 postnatal days ]
    Clinical condition, inflammatory markers


Secondary Outcome Measures :
  1. Attachment of transplant [ Time Frame: 1 to 12 weeks of age ]
    Evaluation of microbiome in comparison to transplant from samples taken from infants weekly at 1-4 weeks of life and at 3 months of age.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women only
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • healthy pregnancy
  • planned cesarean section delivery

Exclusion criteria:

Maternal exclusion criteria:

  • 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)

Infant exclusion criteria:

  • 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): NCT03568734


Locations
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Finland
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Sture Andersson
Investigators
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Principal Investigator: Sture Andersson, Prof Professor of neonatology

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Responsible Party: Sture Andersson, Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03568734     History of Changes
Other Study ID Numbers: SECFLOR
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Sture Andersson, Helsinki University Central Hospital:
microbiome
transplant
infant
newborn