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Microbiome Establishment in Preterm Infants

NCT05803577 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2023-04-07

No results posted yet for this study

Summary

Our bodies are home to millions and millions of microbes (bacteria, fungi and viruses), that live in harmony with us without producing any negative (disease producing) effects. Research is beginning to show that these microbes interact with us to help with our immune system, digestive tract and brain development among many other effects. This community of microbes, known collectively as our microbiome, may commence colonisation while we are developing in the womb and becomes quickly established after we are born. Much remains unknown about how preterm birth affects the development of our microbiome.

The goal of this longitudinal observational study is to gather more information of how and from where we get those first few microbes, the pattern in which our microbiome develops, and how intensive care for a preterm baby affects this.

The main questions it aims to answer are:

* How is the gut microbiome of a very premature infant affected by clinical management practices (e.g. antibiotics, probiotics, feeding) and how does it progress subsequently.
* How do probiotics colonise the preterm gut, and how do they persist once supplementation is discontinued.

Samples will be collected from mothers and their infants during the NICU admission including:

* A rectal swab
* Meconium and stool
* Urine
* Blood
* Expressed breastmilk
* Maternal stool
* Maternal oral swab
* Maternal vaginal or skin swab (depending on mode of delivery)

Samples will be analysed using next generation sequencing techniques to, for example, evaluate microbial composition of the samples or determine functional microbiome-host interactions.

Conditions

  • Prematurity
  • Microbial Colonization

Sponsors & Collaborators

  • University College Cork

    lead OTHER

Principal Investigators

  • Eugene Dempsey · University College Cork

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2022-12-31
Completion
2025-01-31

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 NCT05803577 on ClinicalTrials.gov