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Clinical Trials/NCT03552952
NCT03552952
Recruiting
Not Applicable

Development of Preterm Infant Gut Microbiome

Rambam Health Care Campus1 site in 1 country200 target enrollmentMarch 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Infants
Sponsor
Rambam Health Care Campus
Enrollment
200
Locations
1
Primary Endpoint
Changes in gut microbial abundance over time
Status
Recruiting
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2018
End Date
July 2025
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in gut microbial abundance over time

Time Frame: One year

Preterm infants and full-term infants fecal DNA at different time points

Study Sites (1)

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