Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants

NCT03841994 | Completed DMC

• 1 other identifier: 1801-128-917
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Conditions

Preterm Infants

Keywords

microbiome

Outcome Measures

Primary Outcomes (4)

• The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment

  Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  within 24 hours after birth

• The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment

  Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  2 weeks after birth

• The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment

  Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  3~5 weeks after birth

• The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment

  Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  at 37~40 weeks of postmenstrual age

Secondary Outcomes (5)

• Brain MRI

  at 37~40 weeks of postmenstrual age

• Bayley scales of infant and toddler development, third edition

  at 18~24 months of corrected age

• Incidence of major morbidity

  at 36~40 weeks of postmenstrual age

• Comparison of inflammation markers

  with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age

• Comparison of short chain fatty acid at 4 period

  with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age

Study Arms (1)

Preterm infant cohort

Preterm infants who were born \<28 weeks of gestational age

Eligibility Criteria

• Age: Up to 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants who are born at \< 28 weeks of gestation and admitted to the neonatal intensive care unit at Seoul national university children's hospital

You may qualify if:

• Preterm infants
• born less than 28+0 weeks gestation

You may not qualify if:

• Major congenital anomalies

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (16)

• Cao B, Stout MJ, Lee I, Mysorekar IU. Placental Microbiome and Its Role in Preterm Birth. Neoreviews. 2014 Dec 1;15(12):e537-e545. doi: 10.1542/neo.15-12-e537.

  PMID: 25635174 BACKGROUND

• Choi Y, Kwon Y, Kim DK, Jeon J, Jang SC, Wang T, Ban M, Kim MH, Jeon SG, Kim MS, Choi CS, Jee YK, Gho YS, Ryu SH, Kim YK. Gut microbe-derived extracellular vesicles induce insulin resistance, thereby impairing glucose metabolism in skeletal muscle. Sci Rep. 2015 Oct 29;5:15878. doi: 10.1038/srep15878.

  PMID: 26510393 BACKGROUND

• Cong X, Henderson WA, Graf J, McGrath JM. Early Life Experience and Gut Microbiome: The Brain-Gut-Microbiota Signaling System. Adv Neonatal Care. 2015 Oct;15(5):314-23; quiz E1-2. doi: 10.1097/ANC.0000000000000191.

  PMID: 26240939 BACKGROUND

• Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.

  PMID: 22968153 BACKGROUND

• DiBartolomeo ME, Claud EC. The Developing Microbiome of the Preterm Infant. Clin Ther. 2016 Apr;38(4):733-9. doi: 10.1016/j.clinthera.2016.02.003. Epub 2016 Mar 2.

  PMID: 26947798 BACKGROUND

• Kim MH, Rho M, Choi JP, Choi HI, Park HK, Song WJ, Min TK, Cho SH, Cho YJ, Kim YK, Yang S, Pyun BY. A Metagenomic Analysis Provides a Culture-Independent Pathogen Detection for Atopic Dermatitis. Allergy Asthma Immunol Res. 2017 Sep;9(5):453-461. doi: 10.4168/aair.2017.9.5.453.

  PMID: 28677360 BACKGROUND

• Macfabe DF. Short-chain fatty acid fermentation products of the gut microbiome: implications in autism spectrum disorders. Microb Ecol Health Dis. 2012 Aug 24;23. doi: 10.3402/mehd.v23i0.19260. eCollection 2012.

  PMID: 23990817 BACKGROUND

• Mshvildadze M, Neu J. The infant intestinal microbiome: friend or foe? Early Hum Dev. 2010 Jul;86 Suppl 1(Suppl 1):67-71. doi: 10.1016/j.earlhumdev.2010.01.018. Epub 2010 Feb 8.

  PMID: 20116944 BACKGROUND

• Murgas Torrazza R, Neu J. The developing intestinal microbiome and its relationship to health and disease in the neonate. J Perinatol. 2011 Apr;31 Suppl 1:S29-34. doi: 10.1038/jp.2010.172.

  PMID: 21448201 BACKGROUND

• Rea K, Dinan TG, Cryan JF. The microbiome: A key regulator of stress and neuroinflammation. Neurobiol Stress. 2016 Mar 4;4:23-33. doi: 10.1016/j.ynstr.2016.03.001. eCollection 2016 Oct.

  PMID: 27981187 BACKGROUND

• Sanz Y. Gut microbiota and probiotics in maternal and infant health. Am J Clin Nutr. 2011 Dec;94(6 Suppl):2000S-2005S. doi: 10.3945/ajcn.110.001172. Epub 2011 May 4.

  PMID: 21543533 BACKGROUND

• Stewart CJ, Embleton ND, Marrs EC, Smith DP, Nelson A, Abdulkadir B, Skeath T, Petrosino JF, Perry JD, Berrington JE, Cummings SP. Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease. Microbiome. 2016 Dec 29;4(1):67. doi: 10.1186/s40168-016-0216-8.

  PMID: 28034304 BACKGROUND

• Sung J, Kim N, Kim J, Jo HJ, Park JH, Nam RH, Seok YJ, Kim YR, Lee DH, Jung HC. Comparison of Gastric Microbiota Between Gastric Juice and Mucosa by Next Generation Sequencing Method. J Cancer Prev. 2016 Mar;21(1):60-5. doi: 10.15430/JCP.2016.21.1.60. Epub 2016 Mar 30.

  PMID: 27051651 BACKGROUND

• Yoo JY, Rho M, You YA, Kwon EJ, Kim MH, Kym S, Jee YK, Kim YK, Kim YJ. 16S rRNA gene-based metagenomic analysis reveals differences in bacteria-derived extracellular vesicles in the urine of pregnant and non-pregnant women. Exp Mol Med. 2016 Feb 5;48(2):e208. doi: 10.1038/emm.2015.110.

  PMID: 26846451 BACKGROUND

• Wang X, Buhimschi CS, Temoin S, Bhandari V, Han YW, Buhimschi IA. Comparative microbial analysis of paired amniotic fluid and cord blood from pregnancies complicated by preterm birth and early-onset neonatal sepsis. PLoS One. 2013;8(2):e56131. doi: 10.1371/journal.pone.0056131. Epub 2013 Feb 20.

  PMID: 23437088 BACKGROUND

• Ardissone AN, de la Cruz DM, Davis-Richardson AG, Rechcigl KT, Li N, Drew JC, Murgas-Torrazza R, Sharma R, Hudak ML, Triplett EW, Neu J. Meconium microbiome analysis identifies bacteria correlated with premature birth. PLoS One. 2014 Mar 10;9(3):e90784. doi: 10.1371/journal.pone.0090784. eCollection 2014.

  PMID: 24614698 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

gastric juice, blood, stool, breast milk, transtracheal aspirates

Study Officials

• Ee-Kyung Kim, M.D., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 15, 2019
• Study Start: December 4, 2018
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)