Metagenomic Analysis of Gut Microbiome in Preterm

Microbial Colonization Clinical Trial

— MAGMP  

Official title:

Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235635
• Other study ID #: microbiome in nicu
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 29, 2017
• Start date: July 25, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2017
• Source: Wonju Severance Christian Hospital
• Contact: Byoungkook Lee
• Phone: +82-10-6301-3067
• Email: raphael3067[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization
• Microbial Substitution
• Microbial Superinvasion
• Newborn Morbidity

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Arboleya S, Binetti A, Salazar N, Fernández N, Solís G, Hernández-Barranco A, Margolles A, de Los Reyes-Gavilán CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 1 — View Citation

Butel MJ, Suau A, Campeotto F, Magne F, Aires J, Ferraris L, Kalach N, Leroux B, Dupont C. Conditions of bifidobacterial colonization in preterm infants: a prospective analysis. J Pediatr Gastroenterol Nutr. 2007 May;44(5):577-82. — View Citation

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. Review. — View Citation

Jacquot A, Neveu D, Aujoulat F, Mercier G, Marchandin H, Jumas-Bilak E, Picaud JC. Dynamics and clinical evolution of bacterial gut microflora in extremely premature patients. J Pediatr. 2011 Mar;158(3):390-6. doi: 10.1016/j.jpeds.2010.09.007. Epub 2010 O — View Citation

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. Review. — View Citation

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

Rautava S. Microbial Composition of the Initial Colonization of Newborns. Nestle Nutr Inst Workshop Ser. 2017;88:11-21. doi: 10.1159/000455209. Epub 2017 Mar 27. — View Citation

Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal microbiome	The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants	for 2 years
Secondary	Full Enteral feeding in preterm infants	Days to accomplish a full-enteral feeding in each infants	for 2 years
Secondary	Growth rate	Days to reach 2 kg of body weight in each infants	for 2 years
Secondary	Mortality	Number of patients who died in neonatal intensive care unit.	for 2 years
Secondary	Morbidity	Number of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit.	for 2 years
Secondary	Allergic predisposition	Number of patients who were developed a allergic predisposition at 6 month of postnatal age.	for 2 years