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Development of Preterm Infant Gut Microbiome

R

Rambam Health Care Campus

Status

Enrolling

Conditions

Premature Infants

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03552952
0490-17-RMB CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Preterm infants
Description:
100 preterm infants
Treatment:
Other: No intervention
Term infants
Description:
100 term healthy infants
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Smadar Shilo, MD

Data sourced from clinicaltrials.gov

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