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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Restoration of Microbiota in Neonates

Clinicaltrials.gov identifier NCT03928431

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted September 11, 2020

Study Description

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

  • Condition or Disease:Atopic Dermatitis
    Atopic Asthma
    Immunologic Activity Alteration
  • Intervention/Treatment: Other: Maternal microbiota
  • Phase: N/A
Detailed Description

The primary outcome is to examine if exposure to the maternal vaginal and fecal microbiota directly after birth will halfen the cumulative incidence of Immunoglubulin E (IgE)-associated allergic disease at 2 years of age in CS delivered infants, compared with non-treated CS-delivered infants. The secondary outcomes are to compare the community structure of microbes from mothers and their infants and immunological programming of infants delivered via scheduled CS, with or without exposure to the maternal vaginal and fecal microbiota, from birth until two years of age. The primary and secondary outcomes will also be compared with a reference group of vaginally delivered infants. Sex differences in the incidence and prevalence of allergic diseases have been described. The anticipated benefit of the intervention can be implemented in clinical practice regardless of sex, so that improved conditions for good health are created.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 300 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: In this RCT, 300 infants of healthy mothers (age 18 to 40 years) with uncomplicated pregnancies will be included and the infants followed primarily for two years.
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Restoration of Microbiota in Neonates - a Randomized Controlled Trial
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2024
Arms and interventions
Arm Intervention/treatment
Active Comparator: CS intervention
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
See arm descriptions
Placebo Comparator: CS placebo
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
See arm descriptions
Outcome Measures
  • Primary Outcome Measures: 1. IgE-associated allergic disease [ Time Frame: Two years ]
    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.
  • Secondary Outcome Measures: 1. Immunological programming [ Time Frame: Two years ]
    Immunological programming will be assessd via blood cell count from blood tests at 6,12 nad 24 months in infants delivered via scheduled CS, with or without exposure to the maternal vaginal and fecal microbiota in comparison to infants born vaginally.
  • 2. Development of the microbiota [ Time Frame: Two years ]
    To compare microbial composition between groups, using shotgun metagenomics.
Eligibility Criteria
  • Ages Eligible for Study: up to 15 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Infants of healthy mothers with uncomplicated pregnancies at term, mothers of any
ethnic or social background that can speak, read, and understand Swedish to the extent
that they can consent in Swedish. An additional inclusion criterion for mothers in the
CS groups is vaginal pH ≤ 4 at the time of birth.

Exclusion Criteria:

- Infants of mothers with pre-eclampsia or complicated pregnancies, mothers 40 years of age, genital herpes simplex, genital warts, HIV, Hepatitis B or
complications during delivery, infants delivered prior to 37 weeks of gestation.
Additional exclusion criteria for mothers in the CS group: Mothers positive to Group B
Streptococcus, Group A Streptococcus, bacterial vaginosis, vaginal pH > 4 at the time
of birth. Mothers with fecal samples positive for Salmonella, Shigella, Campylobacter
or Yersinia.

Contacts and Locations
Contacts

Contact: Lars G Engstrand, MD +46706780318 lars.engstrand@ki.se

Contact: Emma LS Fransson, PhD +46708435513 emma.fransson@ki.se

Locations

Sweden
Karolinska Institutet
Stockholm

Sponsors and Collaborators

Karolinska Institutet

Uppsala University

Linkoeping University

Umeå University

Örebro University, Sweden

Investigators

Study Chair: Susanne Nylén, PhD Dept Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm

More Information
  • Responsible Party: Karolinska Institutet
  • ClinicalTrials.gov Identifier: NCT03928431 History of Changes
  • Other Study ID Numbers: 2017/1298-31/1
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: September 11, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: Samples will be stored at Karolinska Biobank and metadata will be linked to these samples with access for all researchers in the study. No data will be available for researchers outside the consortium.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Karolinska Institutet: microbiota
    cesarean section
    vaginal delivery
    allergy
    immunological programming
  • Additional relevant MeSH terms: Dermatitis, Atopic Dermatitis