Infant DevelopmentNCT03236194
Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life
An observational study of Infant Development, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 30 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy full-term mothers and infants delivering at the Penn State Milton S Hershey Medical center.
Who may be able to join
- full-term infant (> 36 0/7 weeks gestational age) without significant morbidity
- nursery/NICU/maternity stay of 7 days or less
- participant children can be (but do not have to be) twins
- English speaking mother
- care provided at an HMC affiliated clinic
- a working telephone number
Who cannot join
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight <2250 grams
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.
- plan for newborn to be adopted
- plan to move from Central Pennsylvania within 1 year
- have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.
Read the detailed description
Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.
This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.
- Conditions
- Infant Development
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome outcome
Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals
Measured: birth to 1 year
Secondary outcomes (2)
Genetic variation
Associations between genetic variation and microbiome diversity
Measured: birth to 1 year
Genetic variation
Genetic variation as it relates to growth outcomes
Measured: birth to 1 year
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 start17 Jul 2017
- Primary completion15 Dec 2017
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Ian M. Paul, MD, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236194
- Sponsor's protocol ID
- PRAMS034493EP
- Status last verified
- Feb 2019
- First submitted
- 25 Jul 2017
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gomez A, Nelson KE. The Oral Microbiome of Children: Development, Disease, and Implications Beyond Oral Health. Microb Ecol. 2017 Feb;73(2):492-503. doi: 10.1007/s00248-016-0854-1. Epub 2016 Sep 14.
PubMed 27628595Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015.
PubMed 25798435Chu DM, Ma J, Prince AL, Antony KM, Seferovic MD, Aagaard KM. Maturation of the infant microbiome community structure and function across multiple body sites and in relation to mode of delivery. Nat Med. 2017 Mar;23(3):314-326. doi: 10.1038/nm.4272. Epub 2017 Jan 23.
PubMed 28112736Backhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. No abstract available.
PubMed 26308884
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life
- ClinicalTrials.gov ID
- NCT03236194
- Acronym / sponsor ID
- PRAMS034493EP
- Conditions
- Infant Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 30 Jan 2019 (actual)
- 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.
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.
Detailed description
Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.
This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy full-term mothers and infants delivering at the Penn State Milton S Hershey Medical center.
Key inclusion criteria (6 listed)
- full-term infant (> 36 0/7 weeks gestational age) without significant morbidity
- nursery/NICU/maternity stay of 7 days or less
- participant children can be (but do not have to be) twins
- English speaking mother
- care provided at an HMC affiliated clinic
Key exclusion criteria (7 listed)
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight <2250 grams
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.
- plan for newborn to be adopted
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
Microbiome outcome
Time frame: birth to 1 year
Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals
2 secondary outcomes
Genetic variation
Time frame: birth to 1 year
Genetic variation
Time frame: birth to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Background: PubMed 27628595Gomez A, Nelson KE. The Oral Microbiome of Children: Development, Disease, and Implications Beyond Oral Health. Microb Ecol. 2017 Feb;73(2):492-503. doi: 10.1007/s00248-016-0854-1. Epub 2016 Sep 14.
- Background: PubMed 25798435Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015.
- Background: PubMed 28112736Chu DM, Ma J, Prince AL, Antony KM, Seferovic MD, Aagaard KM. Maturation of the infant microbiome community structure and function across multiple body sites and in relation to mode of delivery. Nat Med. 2017 Mar;23(3):314-326. doi: 10.1038/nm.4272. Epub 2017 Jan 23.
- Background: PubMed 26308884Backhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. No abstract available.
- 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. 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 Infant Development, run by Milton S. Hershey Medical Center at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 4 Mar 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbiome outcome (time frame: birth to 1 year). 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 NCT03236194, which also lists 4 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 4 Mar 2019.