Atopic Asthma, Atopic Dermatitis, Immunologic Activity Alteration
Conditions
Keywords
microbiota, cesarean section, vaginal delivery, allergy, immunological programming
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
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.
Interventions
OTHERMaternal microbiota
See arm descriptions
Sponsors
Uppsala University
Linkoeping University
Umeå University
Örebro University, Sweden
Jonkoping University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Minutes to 15 Minutes
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgE-associated allergic disease | 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
| Measure | Time frame | Description |
|---|---|---|
| Immunological programming | 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. |
| Development of the microbiota | Two years | To compare microbial composition between groups, using shotgun metagenomics. |
Countries
Sweden
Contacts
Primary ContactLars G Engstrand, MD
Backup ContactMarica C Hamsten, MSc
Outcome results
None listed