Microbial ColonizationMAGMPNCT03235635
Metagenomic Analysis of Gut Microbiome in Preterm
An observational study of Microbial Colonization and Microbial Superinvasion, run by Wonju Severance Christian Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Microbial Colonization, Microbial Superinvasion, Microbial Substitution
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2017to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: newborn infants who were born and admitted on neonatal intensive care unit of Wonju Severance Christian Hospital
Who may be able to join
- 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
Who cannot join
- newborns with congenital anomaly
- newborns with genetic syndrome
- newborns without consent of parents
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Byoungkook Lee, +82-10-6301-3067, raphael3067@gmail.com
About this study
Official title: 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.
Read the 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
- Keywords
- microbiome, preterm, newborn, gut microbiome, allergic predisposition
- Medical subject headings
- Communicable Diseases, Superinfection, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: for 2 years
Secondary outcomes (5)
Full Enteral feeding in preterm infants
Days to accomplish a full-enteral feeding in each infants
Measured: for 2 years
Growth rate
Days to reach 2 kg of body weight in each infants
Measured: for 2 years
Mortality
Number of patients who died in neonatal intensive care unit.
Measured: for 2 years
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.
Measured: for 2 years
Allergic predisposition
Number of patients who were developed a allergic predisposition at 6 month of postnatal age.
Measured: for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start25 Jul 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byoungkook Lee, Wonju Severance Christian Hospital
- Investigators
- Byoungkook Lee, Study chair, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235635
- Sponsor's protocol ID
- microbiome in nicu
- Acronym
- MAGMP
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Publications
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.
PubMed 28346920Butel 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.
PubMed 17460489Turnbaugh 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.
PubMed 17943116Jacquot 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.
PubMed 20961563Arboleya 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.
PubMed 22126419Johnson 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.
PubMed 22473366McElroy 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.
PubMed 22639551Groer 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.
PubMed 25332768
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants
- ClinicalTrials.gov ID
- NCT03235635
- Acronym / sponsor ID
- MAGMP / microbiome in nicu
- Conditions
- Microbial Colonization, Microbial Superinvasion, Microbial Substitution, Newborn Morbidity
- Keywords
- microbiome, preterm, newborn, gut microbiome, allergic predisposition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborn infants who were born and admitted on neonatal intensive care unit of Wonju Severance Christian Hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- newborns with congenital anomaly
- newborns with genetic syndrome
- newborns without consent of parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Full Enteral feeding in preterm infants
Time frame: for 2 years
Growth rate
Time frame: for 2 years
Mortality
Time frame: for 2 years
Morbidity
Time frame: for 2 years
Allergic predisposition
Time frame: for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Results publication: PubMed 28346920Rautava 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.
- Results publication: PubMed 17460489Butel 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.
- Results publication: PubMed 17943116Turnbaugh 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.
- Results publication: PubMed 20961563Jacquot 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.
- Results publication: PubMed 22126419Arboleya 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.
- Results publication: PubMed 22473366Johnson 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.
- Results publication: PubMed 22639551McElroy 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.
- Results publication: PubMed 25332768Groer 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.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
Related trials for Microbial Colonization
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byoungkook Lee study chair
Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Microbial Superinvasion, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byoungkook Lee (+82-10-6301-3067, raphael3067@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiome (time frame: for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235635, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.