Microbial ColonizationNCT04972214
The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome
An observational study of Microbial Colonization, run by CHA University at 1 site in South Korea.
Trial summary
This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microbial Colonization
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2021to 28 Feb 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Very preterm infants born before 32 gestational weeks and admitted to the NICU of CHA Bundang Medical Center
Who may be able to join
- Very preterm infants (< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth
Who cannot join
- Parents refuse to participate/sign informed consent
- Major congenital anomalies
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA Bundang Medical center
Seongnam-si, Gyeonggi-do, 13496
Hye-Rim Kim, 82-10-3676-7097, hei23@naver.com
About this study
This study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)
Read the detailed description
The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.
The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.
The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.
- Conditions
- Microbial Colonization
- Keywords
- intestinal microbiota, very preterm infant, breast milk, preterm formula
- Medical subject headings
- Communicable Diseases
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 |
|---|---|---|
| Very Preterm Infants | preterm infants were born at gestational age of less than 32 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal microbiome composition according to the type of feeding
comparison of intestinal microbiome with 16s RNA gene specific sequencing in stool
Measured: within 24 hours after birth
intestinal microbiome composition according to the type of feeding
comparison of intestinal microbiome with 16s RNA gene specific sequencing
Measured: 2 weeks after birth
intestinal microbiome composition according to the type of feeding
comparison of intestinal microbiome with 16s RNA gene specific sequencing
Measured: 4 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start17 May 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye-Rim Kim, CHA University
- Investigators
- Hye-Rim Kim, MD, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972214
- Sponsor's protocol ID
- 2021-03-062-004
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Infant Feeding Type on Preterm Infant's Intestinal Microbiome
- ClinicalTrials.gov ID
- NCT04972214
- Acronym / sponsor ID
- 2021-03-062-004
- Conditions
- Microbial Colonization
- Keywords
- intestinal microbiota, very preterm infant, breast milk, preterm formula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 22 Jul 2021 (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 study aims to examine the factors associated with preterm infant's intestinal microbiota depending on feeding type (breast milk or preterm formula)
Detailed description
The gut microbiome has been increasingly found to affect human health. Feeding plays an important role in determining the composition and diversity of the neonatal gut microbiome. Preterm infants are at a high risk of gut microbiota disruption and dysbiosis because of physiological immaturity and environmental factors. In preterm infants, breast milk has been associated with improved growth and cognitive development and a reduced risk of necrotizing enterocolitis and late onset sepsis.
The objective of study is to determine the impact of feeding type on gut microbiome of very preterm infants admitted in a neonatal intensive care unit (NICU). Meconium and the additional 2 fecal samples will be collected from preterm infants. Fecal samples will be collected every 14 days, during 28 days, from diapers into sterile tubes. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.
The type of infant feeding (breast milk or preterm formula) is recorded daily to classify the type of infant feeding received during the 14 days prior to each fecal sample collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very Preterm Infants | – | –preterm infants were born at gestational age of less than 32 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Very preterm infants born before 32 gestational weeks and admitted to the NICU of CHA Bundang Medical Center
Key inclusion criteria (1 listed)
- Very preterm infants (< 32 weeks gestational age) admitted in the NICU of CHA Bundang Medical Center within the first 24 hours after birth
Key exclusion criteria (2 listed)
- Parents refuse to participate/sign informed consent
- Major congenital anomalies
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 composition according to the type of feeding
Time frame: within 24 hours after birth
comparison of intestinal microbiome with 16s RNA gene specific sequencing in stool
intestinal microbiome composition according to the type of feeding
Time frame: 2 weeks after birth
comparison of intestinal microbiome with 16s RNA gene specific sequencing
intestinal microbiome composition according to the type of feeding
Time frame: 4 weeks after birth
comparison of intestinal microbiome with 16s RNA gene specific sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Hye-Rim Kim, MD principal investigator
CHA Bundang Medical Center
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, run by CHA University 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 1 inclusion and 2 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 27 Jul 2021. 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 Hye-Rim Kim, MD (82-10-3676-7097, hei23@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal microbiome composition according to the type of feeding (time frame: within 24 hours after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2021.