NEC - Necrotizing EnterocolitisNCT06850896
Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
An observational study of NEC - Necrotizing Enterocolitis, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants. Read more about this study
- Who is it for?
- Ages 24 to 36 weeks
- Conditions the study is for
- NEC - Necrotizing Enterocolitis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 24 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This study will enroll newborns admitted to the neonatal unit of Jilin University First Hospital from November 2024 to November 2027.
Who may be able to join
- Newborns admitted within 72 hours of birth
- Gestational age 24-36 weeks (preterm) and term infants
- Informed consent obtained from parents or guardian
Who cannot join
- Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease)
- Severe systemic or organ-specific diseases
- Expected mortality due to severe illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns: a Prospective Cohort Study
This prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants. The study will explore the correlation between antibiotic exposure, gut microbiota colonization, and 5-hydroxytryptamine (5-HT) levels, which are critical for gastrointestinal motility. The findings may provide insights into optimizing antibiotic use and improving gastrointestinal health in neonates.
- Conditions
- NEC - Necrotizing Enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing
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 Infants with Antibiotic Exposure | Description: Newborns with gestational age 24-36 weeks who receive antibiotics within the first 72 hours of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota
Impact of antibiotic exposure on gut microbiota colonization assessed by 16S rRNA sequencing.
Measured: Enrollment Period: This is the time during which participants will be recruited and enrolled into the study. You have specified that enrollment will occur from November 2024 to November 2027. Intervention Period: Since this is an observational study, the
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Feb 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NEC - Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850896
- Sponsor's protocol ID
- 25K041-001
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang S, Zhang L, Yan W, Li S, Han J, Zhou Q, Yang Y, Lee SK, Cao Y; REIN-EPIQ Study Group. Antibiotic Use in Neonatal Intensive Care Units in China: A Multicenter Cohort Study. J Pediatr. 2021 Dec;239:136-142.e4. doi: 10.1016/j.jpeds.2021.08.067. Epub 2021 Aug 28.
PubMed 34461063
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06850896
- Acronym / sponsor ID
- 25K041-001
- Conditions
- NEC - Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 28 Feb 2025 (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 prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants. The study will explore the correlation between antibiotic exposure, gut microbiota colonization, and 5-hydroxytryptamine (5-HT) levels, which are critical for gastrointestinal motility. The findings may provide insights into optimizing antibiotic use and improving gastrointestinal health in neonates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Infants with Antibiotic Exposure | – | –Description: Newborns with gestational age 24-36 weeks who receive antibiotics within the first 72 hours of life. |
Who may qualify
- Ages
- 24 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will enroll newborns admitted to the neonatal unit of Jilin University First Hospital from November 2024 to November 2027.
Key inclusion criteria (3 listed)
- Newborns admitted within 72 hours of birth
- Gestational age 24-36 weeks (preterm) and term infants
- Informed consent obtained from parents or guardian
Key exclusion criteria (3 listed)
- Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease)
- Severe systemic or organ-specific diseases
- Expected mortality due to severe illness
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
gut microbiota
Time frame: Enrollment Period: This is the time during which participants will be recruited and enrolled into the study. You have specified that enrollment will occur from November 2024 to November 2027. Intervention Period: Since this is an observational study, the
Impact of antibiotic exposure on gut microbiota colonization assessed by 16S rRNA sequencing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 34461063Jiang S, Zhang L, Yan W, Li S, Han J, Zhou Q, Yang Y, Lee SK, Cao Y; REIN-EPIQ Study Group. Antibiotic Use in Neonatal Intensive Care Units in China: A Multicenter Cohort Study. J Pediatr. 2021 Dec;239:136-142.e4. doi: 10.1016/j.jpeds.2021.08.067. Epub 2021 Aug 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 NEC - Necrotizing Enterocolitis, run by The First Hospital of Jilin University at 1 site in China.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota (time frame: Enrollment Period: This is the time during which participants will be recruited and enrolled into the study. You have specified that enrollment will occur from November 2024 to November 2027. Intervention Period: Since this is an observational study, the). 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 NCT06850896, which also lists 1 linked publication.
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 28 Feb 2025.