Cesarean Section and Intestinal Flora of the Newborn (SECFLOR)
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|ClinicalTrials.gov Identifier: NCT03568734|
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Microbiome||Other: Fecal transplant||Not Applicable|
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.
|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)|
|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|
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.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 0-3 postnatal days ]Clinical condition, inflammatory markers
- 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.
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
|Helsinki University Hospital|
|Helsinki, Uusimaa, Finland, 00029|
|Principal Investigator:||Sture Andersson, Prof||Professor of neonatology|