Preterm InfantNCT03373721
Gut Microbiota of Preterm Infants and Full-term Infants at Early Life
An observational study of Preterm Infant and Gut Microbiome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. Read more about this study
- Who is it for?
- Ages 1 day to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Gut Microbiome
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2014to 20 Dec 2028
- 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 1 day to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: About 50 preterm infants and 50 full-term healthy infants
Who may be able to join
- Preterm infants
- gestational age <37 weeks;
- no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
- hospital stay > 7 days;
Who cannot join
- NICU stay less than 7 days
- Necrotizing enterocolitis infant
- Control group:
- Full-term healthy infants;
- gestational age >37 weeks;
- vaginally born;
- no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Jie Jia, PhD, 008613122322289, jie.jia@shsmu.edu.cn
About this study
Official title: Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.
The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.
Read the detailed description
Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .
- Conditions
- Preterm Infant, Gut Microbiome
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in gut microbiota over time and in relation to antibiotic treatment
Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants
Measured: 0-7 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start20 Jul 2014
- Primary completion1 Nov 2026 (estimated)
- Study completion20 Dec 2028 (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 Preterm InfantStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Jia, PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373721
- Sponsor's protocol ID
- XH-17-009
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2017
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jia J, Shuai M, Yan W, Tang Q, Wang B, Tang W, Wang P, Zhang T, Yang S, Zhang Y, Liu Q, Fu Y, Cai W, Zheng JS. Conserved Covarying Gut Microbial Network in Preterm Infants and Childhood Growth During the First 5 Years of Life: A Prospective Cohort Study. Am J Clin Nutr. 2023 Sep;118(3):561-571. doi: 10.1016/j.ajcnut.2023.07.019. Epub 2023 Jul 29.
PubMed 37517614
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Succession of Preterm Infants and Full-term Infants at Early Life
- ClinicalTrials.gov ID
- NCT03373721
- Acronym / sponsor ID
- XH-17-009
- Conditions
- Preterm Infant, Gut Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Jul 2014 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 14 Dec 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.
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.
The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.
Detailed description
Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- About 50 preterm infants and 50 full-term healthy infants
Key inclusion criteria (4 listed)
- Preterm infants
- gestational age <37 weeks;
- no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
- hospital stay > 7 days;
Key exclusion criteria (7 listed)
- NICU stay less than 7 days
- Necrotizing enterocolitis infant
- Full-term healthy infants;
- gestational age >37 weeks;
- vaginally born;
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
changes in gut microbiota over time and in relation to antibiotic treatment
Time frame: 0-7 years after birth
Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants
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 17 Apr 2024.
- Derived from this study: PubMed 37517614Jia J, Shuai M, Yan W, Tang Q, Wang B, Tang W, Wang P, Zhang T, Yang S, Zhang Y, Liu Q, Fu Y, Cai W, Zheng JS. Conserved Covarying Gut Microbial Network in Preterm Infants and Childhood Growth During the First 5 Years of Life: A Prospective Cohort Study. Am J Clin Nutr. 2023 Sep;118(3):561-571. doi: 10.1016/j.ajcnut.2023.07.019. Epub 2023 Jul 29.
- Individual participant dataSharing planned: Undecided
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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.
Jie Jia, PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 Preterm Infant and Gut Microbiome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Apr 2024. 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?
Contact Jie Jia, PhD (0086-13122322289, jie.jia@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in gut microbiota over time and in relation to antibiotic treatment (time frame: 0-7 years after birth). 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 NCT03373721, 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 17 Apr 2024.