Cesarean Section and Intestinal Flora of the Newborn

Intestinal Microbiome Clinical Trial

— SECFLOR  

Official title:

Cesarean Section and Intestinal Flora of the Newborn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568734
• Other study ID #: SECFLOR
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 31, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Microbiome

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Sture Andersson

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Clinical condition, inflammatory markers	0-3 postnatal days
Secondary	Attachment of transplant	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.	1 to 12 weeks of age