Development of Preterm Infant Gut Microbiome

NCT ID: NCT03552952

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-08

Study Completion Date

2025-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Premature Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm infants

100 preterm infants

No intervention

Intervention Type OTHER

No intervention

Term infants

100 term healthy infants

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Smadar Shilo, MD

Role: CONTACT

+972-7774400

Facility Contacts

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Smadar Shilo, MD

Role: primary

97247774400

Other Identifiers

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0490-17-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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