Restoration of Microbiota in Neonates

Atopic Dermatitis Clinical Trial

— RoMaNs  

Official title:

Restoration of Microbiota in Neonates - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03928431
• Other study ID #: 2017/1298-31/1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 15, 2026

Study information

• Verified date: April 2023
• Source: Karolinska Institutet
• Contact: Lars G Engstrand, MD
• Phone: +46706780318
• Email: lars.engstrand[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 15, 2026
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Minutes to 15 Minutes

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Asthma
• Atopic Dermatitis
• Dermatitis
• Immunologic Activity Alteration

Intervention

Other:
• Maternal microbiota
See arm descriptions

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Karolinska Institutet	Jonkoping University, Linkoeping University, Örebro University, Sweden, Umeå University, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Two years
Secondary	Development of the microbiota	To compare microbial composition between groups, using shotgun metagenomics.	Two years