Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study

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

Intervention / Treatment
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* Other: Fecal microbial transplant
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Number of enrolled mothers describes the number of mothers included for screening.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal microbial transplant<br>The participants of the experimental arm will receive an oral fecal microbial transplant after delivery | Other: Fecal microbial transplant<br>* Fecal microbial transplant<br>|
| Placebo Comparator: Placebo group<br>The participants of the placebo arm will receive an oral placebo after delivery | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing | 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 | At three months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in markers of cow milk immunoglobulin Es | The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group. | At 12 months of age | 
| Difference in markers of aeroallergen immunoglobulin Es | The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group. | At 24 months of age | 
| Difference in tetanus and measles, mumps and rubella vaccine responses | The difference in vaccine responses between the intervention group and the placebo group (as Immunoglobulin G milli-International Units/milliliter). | At 12 and 24 months of age | 
| Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing | 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 | At 6, 12 and 24 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant, Cesarean section, inflammatory response, Infant