Health TrialsbyHealthPanel

Restoration of Microbiota in Neonates

ConditionsAtopic DermatitisAtopic AsthmaImmunologic Activity Alteration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorKarolinska Institutet

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maternal microbiota

    Other intervention

    See arm descriptions

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: vaginally deliveredNo intervention 0 interventions
Group B: CS interventionActive comparator 1 intervention
Group C: CS placeboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Two years

Secondary outcomes

1

Immunological programming

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.

Time frame
Two years
2

Development of the microbiota

To compare microbial composition between groups, using shotgun metagenomics.

Time frame
Two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Uppsala University

Collaborator

Linkoeping University

Collaborator

Umeå University

Collaborator

Örebro University, Sweden

Collaborator

Jonkoping University

Collaborator

Source ClinicalTrials.gov
Apply now