Metagenomic Analysis of Gut Microbiome in Preterm

NCT ID: NCT03235635

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2019-02-28

Brief Summary

This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.

Detailed Description

Microbiome is the collection of all the microorganisms living in association with the human body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average human body number are ten times more than human cells and have about 1000 more genes than are present in the human genome. There are symbiotic relationships between human and microbiome. If investigators are able to know about relationships between newborn and intestinal microbiome, mortality and morbidity in preterm infants may be improved. The investigators will collect the first and weekly stool of participants and analyze DNA of microbiome thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and full-term infants) will be compared. The investigators expect that a mean distribution of intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that relationships between mortality, morbidity and intestinal microbiome.

Conditions

Microbial Colonization; Microbial Superinvasion; Microbial Substitution; Newborn Morbidity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm

newborn infants were born with a gestational age of less than 32 weeks

No interventions assigned to this group

Late preterm

newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks

No interventions assigned to this group

full-term

newborn infants were born with a gestational age of greater than or equal to 37 weeks

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• preterm infants who were born at gestational age of less than 36 weeks from approval date to Feb 28th 2019
• full-term infants who were born at gestational age of greater than 37 weeks from approval date to Feb 28th 2019

Exclusion Criteria

• newborns with congenital anomaly
• newborns with genetic syndrome
• newborns without consent of parents

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Byoungkook Lee

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byoungkook Lee

Role: STUDY_CHAIR

Wonju Severance Christian Hospital

Locations

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Byoungkook Lee

Role: CONTACT

raphael3067@gmail.com

+82-10-6301-3067

Facility Contacts

Byoungkook Lee

Role: primary

raphael3067@gmail.com

+82-10-6301-3067

References

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 17460489 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 20961563 (View on PubMed)

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Reference Type: RESULT

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Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.

Reference Type: RESULT

PMID: 22473366 (View on PubMed)

McElroy SJ, Weitkamp JH. Innate Immunity in the Small Intestine of the Preterm Infant. Neoreviews. 2011 Sep 1;12(9):e517-e526. doi: 10.1542/neo.12-9-e517.

Reference Type: RESULT

PMID: 22639551 (View on PubMed)

Groer MW, Luciano AA, Dishaw LJ, Ashmeade TL, Miller E, Gilbert JA. Development of the preterm infant gut microbiome: a research priority. Microbiome. 2014 Oct 13;2:38. doi: 10.1186/2049-2618-2-38. eCollection 2014.

Reference Type: RESULT

PMID: 25332768 (View on PubMed)

Other Identifiers

microbiome in nicu

Identifier Type: -

Identifier Source: org_study_id