Skip to content

Development of Preterm Infant Gut Microbiome

Development of Preterm Infant Gut Microbiome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03552952
Enrollment
200
Registered
2018-06-12
Start date
2018-03-08
Completion date
2025-07-31
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infants

Brief summary

This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

Detailed description

Preterm birth, defined as childbirth occurring at less than 37 completed weeks, is a major determinant of neonatal mortality and morbidity and has long-term adverse consequences for health. The human microbiome is the collective genome of the immense ecosystem of trillions of microbes and is considered to have a coevolved relationship with the immune system and fundamental roles in multiple aspects of human physiology. Little is known about the developmental of the gut microbiome in preterm infants as they grow and mature. One hundred premature infants born in Rambam healthcare campus in Haifa, Israel, will be recruited to the study and 100 term healthy infants will be recruited as controls. Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study. Fecal samples will be collected during the hospital stay and in follow-up visits. Blood samples will be taken during the hospital stay. The investigators will analyze the data from this clinical cohort using computational and experimental approaches for extracting novel information on microbiome composition and development, gene function, metabolic pathways and metabolite production.

Interventions

OTHERNo intervention

No intervention

Sponsors

Weizmann Institute of Science
CollaboratorOTHER
Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Premature and term infants born in Rambam healthcare campus in Haifa, Israel

Exclusion criteria

* Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Changes in gut microbial abundance over timeOne yearPreterm infants and full-term infants fecal DNA at different time points

Countries

Israel

Contacts

Primary ContactSmadar Shilo, MD
smadar.shilo@weizmann.ac.il+972-7774400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026