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Missing Microbes in Infants Born by Cesarean Section

NCT04134819 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-01-09

No results posted yet for this study

Summary

General adult healthy pregnant females in total 400, as well as their infants will be recruited. It is expected 67% will be vaginally delivered and 33% will be C Section deliveries. It is expected that of these groups that 40% of these women will be treated with antibiotics during their pregnancy. All C Section women (including emergency C Section) will be treated with IV Cefazolin at the time of incision, in theatre, to prevent internal wound infection.

Primary objective The effect of maternal antibiotic administration during pregnancy upon the development of the intestinal microbiota until the age of two years; of C-section delivered infants compared to C-section delivered infants born to non-antibiotic treated pregnant women. To develop a cohort of vaginally delivered infants to isolate the 'missing microbes' (intestinal) in the groups above.

Secondary objective

The effect of maternal antibiotics on the developing infant by:

* Anthropometric assessment: Body weight and Body length
* Bayley scale of infant development test at age 2 years

Ancillary

* To isolate and characterise bacterial strains from fresh healthy infant faeces that are altered in the stools from C-section delivered and antibiotic treated infants and compared to vaginally delivered infants.
* The effect of maternal antibiotic treatment on the human milk microbiome during lactation
* Stress hormone levels of mothers and infants
* Mental health questionnaire of mothers
* Food frequency questionnaire of mothers Exploratory
* To identify bacterial strains that can be further developed into probiotic products to help replenish depleted microbiota in the infant gut, born by C Section and or treated with antibiotics

Conditions

  • C Section

Sponsors & Collaborators

  • Dupont Applied Biosciences

    collaborator INDUSTRY

  • University College Cork

    lead OTHER

Principal Investigators

  • Eugenen M Dempsey, PhD MD · APC Microbiome Ireland, University College Cork, Ireland.

Eligibility

Min Age
22 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-07-30
Completion
2025-05-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04134819 on ClinicalTrials.gov