Status:
RECRUITING
Missing Microbes in Infants Born by Cesarean Section
Lead Sponsor:
University College Cork
Collaborating Sponsors:
Dupont Applied Biosciences
Conditions:
C Section
Eligibility:
All Genders
22-40 years
Brief 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 tha...
Detailed Description
The intestinal microbiota in early life plays a major role in infant health and development, impacting on maturation of the immune system, protection against pathogens, and influencing the long-term m...
Eligibility Criteria
Inclusion
- Pregnant females of age 22 to 40 years
- Singleton pregnancy
- Infants born within the Cork University Maternity Hospital
- Women who are intending to exclusively breast feed their infant for a minimum of 6 weeks
- Mothers who give birth to full term infants greater than 35 weeks' gestation
- Infants who are born healthy with no underlying illness, syndrome or chronic disease
- Participants who agree to maintain their usual dietary habits throughout the trial period
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to participate in the study and willing to comply with the protocol and study restrictions.
Exclusion
- Sick infants who are admitted to the neonatal unit
- Stillbirth or live birth where the baby is born alive but dies shortly after.
- Infants born less than 35 (34 weeks +6 days) weeks gestation
- Infants who are formula fed exclusively before 6 weeks of age
- Mothers with insulin dependent gestational diabetes)
- Mothers and infants who will live more than 45 minutes (driving) from hospital on discharge.
- Self-declare history of alcohol abuse (for females: \>3 drinks on any single day and \>7 drinks per week
- Self-declare use of illicit drugs
- Participants under administrative or legal supervision.
- Participation in another study with any investigational product within 60 days of screening
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04134819
Start Date
July 1 2019
End Date
May 30 2025
Last Update
January 9 2024
Active Locations (1)
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1
Cork University Maternity Hospital, APC Microbiome Ireland, University College Cork, and Teagasc Food Research Centre, Moorepark, Fermoy, Co. Cork. IRELAND
Cork, Munster, Ireland