Cesarean Section and Intestinal Flora of the Newborn

NCT ID: NCT03568734

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-27
• Study Completion Date: 2018-12-31

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

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.

Conditions

Intestinal Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Transplant arm

Fecal transplant sample given to child at delivery

Group Type: EXPERIMENTAL

Fecal transplant

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy pregnancy
• planned cesarean section delivery

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)

• Apgar score of less than 8
• disturbances of neonatal adaptation (such as transient tachypnea of the newborn)
• antibiotic treatment of the newborn before discharge

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sture Andersson

OTHER

Sponsor Role: lead

Responsible Party

Sture Andersson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sture Andersson, Prof

Role: PRINCIPAL_INVESTIGATOR

Professor of neonatology

Locations

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Countries

Finland

References

Korpela K, Helve O, Kolho KL, Saisto T, Skogberg K, Dikareva E, Stefanovic V, Salonen A, Andersson S, de Vos WM. Maternal Fecal Microbiota Transplantation in Cesarean-Born Infants Rapidly Restores Normal Gut Microbial Development: A Proof-of-Concept Study. Cell. 2020 Oct 15;183(2):324-334.e5. doi: 10.1016/j.cell.2020.08.047. Epub 2020 Oct 1.

Reference Type: DERIVED

PMID: 33007265 (View on PubMed)

Other Identifiers

SECFLOR

Identifier Type: -

Identifier Source: org_study_id