- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03235635
Metagenomic Analysis of Gut Microbiome in Preterm (MAGMP)
July 29, 2017 updated by: Byoungkook Lee, Wonju Severance Christian Hospital
Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants
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.
Study Overview
Status
Unknown
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.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Byoungkook Lee
- Phone Number: +82-10-6301-3067
- Email: raphael3067@gmail.com
Study Locations
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, Korea, Republic of, 26426
- Recruiting
- Wonju Severance Christian Hospital
-
Contact:
- Byoungkook Lee
- Phone Number: +82-10-6301-3067
- Email: raphael3067@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 day (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
newborn infants who were born and admitted on neonatal intensive care unit of Wonju Severance Christian Hospital
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Preterm
newborn infants were born with a gestational age of less than 32 weeks
|
Late preterm
newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks
|
full-term
newborn infants were born with a gestational age of greater than or equal to 37 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal microbiome
Time Frame: for 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Full Enteral feeding in preterm infants
Time Frame: for 2 years
|
Days to accomplish a full-enteral feeding in each infants
|
for 2 years
|
Growth rate
Time Frame: for 2 years
|
Days to reach 2 kg of body weight in each infants
|
for 2 years
|
Mortality
Time Frame: for 2 years
|
Number of patients who died in neonatal intensive care unit.
|
for 2 years
|
Morbidity
Time Frame: for 2 years
|
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
|
Allergic predisposition
Time Frame: for 2 years
|
Number of patients who were developed a allergic predisposition at 6 month of postnatal age.
|
for 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Byoungkook Lee, Wonju Severance Christian Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1038/nature06244.
- 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.
- 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. doi: 10.1097/MPG.0b013e3180406b20.
- 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 Oct 18.
- Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2017
Primary Completion (Anticipated)
February 28, 2019
Study Completion (Anticipated)
February 28, 2019
Study Registration Dates
First Submitted
July 17, 2017
First Submitted That Met QC Criteria
July 29, 2017
First Posted (Actual)
August 1, 2017
Study Record Updates
Last Update Posted (Actual)
August 1, 2017
Last Update Submitted That Met QC Criteria
July 29, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- microbiome in nicu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Yes: There is a plan to make IPD and related data dictionaries available.
IPD Sharing Time Frame
starting from august 2017 until February 2019
IPD Sharing Access Criteria
neonatology pediatrics infections
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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