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Development of Preterm Infant Gut Microbiome

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ClinicalTrials.gov Identifier: NCT03552952
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Rambam Health Care Campus

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

Condition or disease Intervention/treatment
Premature Infants Other: No intervention

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Preterm Infant Gut Microbiome
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Group/Cohort Intervention/treatment
Preterm infants
100 preterm infants
Other: No intervention
No intervention

Term infants
100 term healthy infants
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Changes in gut microbial abundance over time [ Time Frame: One year ]
    Preterm infants and full-term infants fecal DNA at different time points



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premature and term infants
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.

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03552952     History of Changes
Other Study ID Numbers: 0490-17-RMB CTIL
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No