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Restoration of Microbiota in Neonates (RoMaNs)

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ClinicalTrials.gov Identifier: NCT03928431
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Uppsala University
Linkoeping University
Umeå University
Örebro University
Information provided by (Responsible Party):
Lars Engstrand, Karolinska Institutet

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 Intervention/treatment Phase
Atopic Dermatitis Atopic Asthma Immunologic Activity Alteration Other: Maternal microbiota Not Applicable

Detailed Description:

Our 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.

Our 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.


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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Restoration of Microbiota in Neonates - a Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: vaginally delivered
A non-randomized reference group of vaginally delivered infants.
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




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


Secondary Outcome Measures :
  1. Immunological programming [ Time Frame: Two years ]
    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.



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Ages Eligible for Study:   up to 15 Minutes   (Child)
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 <18 years or >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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928431


Contacts
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Contact: Lars G Engstrand, MD +46706780318 lars.engstrand@ki.se
Contact: Emma LS Fransson, PhD +46708435513 emma.fransson@ki.se

Locations
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Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden, 171 65
Contact: Emma LS Fransson, PhD    +46708435513    emma.fransson@k.se   
Sponsors and Collaborators
Karolinska Institutet
Uppsala University
Linkoeping University
Umeå University
Örebro University
Investigators
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Study Chair: Susanne Nylén, PhD Dept Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm

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Responsible Party: Lars Engstrand, professor, MD, 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: April 26, 2019
Last Verified: April 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lars Engstrand, Karolinska Institutet:
microbiota
cesarean section
vaginal delivery
allergy
immunological programming

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases