Restoration of Microbiota in Neonates

NCT03928431 | Recruiting

• 1 other identifier: 2017/1298-31/1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine the effect of exposure of cesarean section (CS) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood

Conditions

Atopic Dermatitis; Atopic Asthma; Immunologic Activity Alteration

Keywords

microbiota; cesarean section; vaginal delivery; allergy; immunological programming

Outcome Measures

Primary Outcomes (1)

• IgE-associated allergic disease

  Incidence of Immunoglubulin E (IgE)-associated allergic disease at 2 years of age in CS delivered infants, compared with non-treated CS-delivered infants and vaginally delivered controls. Skin-puncture tests will be performed at infant age 6 months, 12 months and child age 24 months.

  Two years

Secondary Outcomes (2)

• Immunological programming

  Two years

• Development of the microbiota

  Two years

Study Arms (3)

vaginally delivered

NO INTERVENTION

A non-randomized reference group of vaginally delivered infants.

CS intervention

ACTIVE COMPARATOR

A piece of gauze soaked with saline (0.9%) will be placed in the birth canal 2 hours before the CS by the study midwife, using sterile glows. Before the CS procedure begins, the gauze will be removed from the vagina and then immediately "contaminated" by a swab carrying maternal fecal microbiota. The swab is contaminated by introducing it 3 cm into the anal canal and by rotating it for 10-20 s. Immediately after birth, the study midwife will swab the neonate with the gauze in multiple body sites by a standardized manner and then swab maternal breasts and chest skin. The neonate will then be placed on the maternal chest to initiate breast-feeding.

Other: Maternal microbiota

CS placebo

PLACEBO COMPARATOR

See above - the gauze will be exchanged to a clean gauze (soaked with saline). Immediately after birth, the study midwife will swab the neonate with the gauze in multiple body sites by a standardized manner and then swab maternal breasts and chest skin. The neonate will then be placed on the maternal chest to initiate breast-feeding.

Other: Maternal microbiota

Interventions

Maternal microbiota OTHER

See arm descriptions

CS intervention; CS placebo

Eligibility Criteria

• Age: 5 Minutes - 15 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator
• Linkoeping University: collaborator
• Umeå University: collaborator
• Örebro University, Sweden: collaborator
• Jonkoping University: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 171 65, Sweden

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Susanne Nylén, PhD

  Dept Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm

  STUDY CHAIR

Central Study Contacts

Lars G Engstrand, MD

CONTACT

+46706780318; lars.engstrand@ki.se

Marica C Hamsten, MSc

CONTACT

+46675555872; marica.hamsten@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Mothers who give birth by CS will be randomized to expose their neonate to samples of their vaginal and fecal microbiome after birth or to placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD

Model Details: In this RCT, 330 infants of healthy mothers (age 18 to 40 years) with uncomplicated pregnancies will be included and the infants followed primarily for two years. The number has been increased to cover for potential drop-outs.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 26, 2019
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-04

Locations

SE (1)