Cesarean Section and Intestinal Flora of the Newborn (SECFLOR)

Sture Andersson

Status

Completed

Conditions

Intestinal Microbiome

Treatments

Other: Fecal transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT03568734

SECFLOR

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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