Obesity, ChildhoodMAGICNCT03001167
Microbiome, Antibiotics, and Growth Infant Cohort
An observational study of Obesity, Childhood and Antibiotic Side Effect, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation. Read more about this study
- Who is it for?
- Ages Up to 96 hours
- Conditions the study is for
- Obesity, Childhood, Antibiotic Side Effect
- How many people
- 509 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2016to 9 Jun 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 Up to 96 hours
- All sexes
- No healthy volunteers
- Child
Study population: Our study population will be comprised of children born at Pennsylvania Hospital between 2016-2018 and subsequently, followed in the Children's Hospital of Philadelphia (CHOP) Care Network or one of four other local primary care pediatric practices.
Who may be able to join
- Born at Pennsylvania Hospital
- Recruited at <120 hours of age
- Born at ≥36 0/7 weeks gestation
- Birth weight ≥2000 grams
- Parents plan to receive well-child care in the Children's Hospital of Philadelphia (CHOP) network, Society Hill Pediatrics, Center City Pediatrics, Penn Medicine or South Philly Pediatrics
- Biological mother is the legal guardian, or the child is born from a surrogacy with guardianship immediately transferred in hospital
Who cannot join
- Child in neonatal intensive care unit (NICU) for >120 cumulative hours
- Biological mother NOT legal guardian, except surrogacy where guardianship is transferred at birth
- Biological mother NOT primary caretaker, except surrogacy where guardianship is transferred at birth
- Biological mother < 18 years of age
- Child has culture confirmed (blood or cerebrospinal fluid cultures) infection
- Biological mother is non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Early Life Antibiotics, Gut Microbiome Development, and Risk of Childhood Obesity
This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation.
Read the detailed description
Perinatal and infant antibiotic exposures are common and have been linked to changes in the gut microbiome, which plays a central role in health and disease. Childhood obesity is an epidemic and animal models have linked antibiotic induced changes in the microbiome with increased adiposity. Infants become colonized with trillions of bacteria in the first few hours of life. During this time period, their nascent immune system develops tolerance to commensal microbes
The primary objectives are to measure the impact of common perinatal and early childhood antibiotic exposures on the structure and function of the developing gut microbiome. To determine the association between common perinatal and early childhood antibiotic exposures and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for the association between microbiome changes over time and the rate of weight/adiposity gain in a large birth cohort of children. To determine the normal developmental pattern by which healthy children develop antibodies in their blood against the microbes that naturally colonize their intestines. To determine the association between immunostimulation and protection from persistent colonization in humans.
- Conditions
- Obesity, Childhood, Antibiotic Side Effect
- Keywords
- Microbiome, Antibiotics, Growth
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative microbial diversity
Measured: 24 months
weight trajectory adjusted for time varying length
Measured: 24 months
Secondary outcomes (7)
total number of individual bacterial taxa
Measured: 24 months
expression levels of bacterial gene categories
Measured: 24 months
fat stores in the upper arm/extremity
Skinfolds at the triceps are measured (0.1 mm) with a skinfold caliper
Measured: 24 months
fat stores in the upper back/trunk
Skinfolds at the superiliac and subscapular sites are measured (0.1 mm) with a skinfold caliper
Measured: 24 months
supine length trajectory
Measured: 24 months
determine the association between immunostimulation and protection from persistent colonization in humans
Measured: 24 months
Use autologous serum antibodies to "tag" fecal microbes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start9 Dec 2016
- Primary completion22 Oct 2021
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Gerber, MD, PhD, Principal investigator, Children's Hospital of PhiladelphiaDan Knights, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001167
- Sponsor's protocol ID
- 15-012623
- Other IDs
- R01AI121383
- Acronym
- MAGIC
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2016
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: De-identified individual participant data will be shared with collaborators at the Knights Lab at the University of Minnesota.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Life Antibiotics, Gut Microbiome Development, and Risk of Childhood Obesity
- ClinicalTrials.gov ID
- NCT03001167
- Acronym / sponsor ID
- MAGIC / 15-012623
- Conditions
- Obesity, Childhood, Antibiotic Side Effect
- Keywords
- Microbiome, Antibiotics, Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Minnesota, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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 cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation.
Detailed description
Perinatal and infant antibiotic exposures are common and have been linked to changes in the gut microbiome, which plays a central role in health and disease. Childhood obesity is an epidemic and animal models have linked antibiotic induced changes in the microbiome with increased adiposity. Infants become colonized with trillions of bacteria in the first few hours of life. During this time period, their nascent immune system develops tolerance to commensal microbes
The primary objectives are to measure the impact of common perinatal and early childhood antibiotic exposures on the structure and function of the developing gut microbiome. To determine the association between common perinatal and early childhood antibiotic exposures and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for the association between microbiome changes over time and the rate of weight/adiposity gain in a large birth cohort of children. To determine the normal developmental pattern by which healthy children develop antibodies in their blood against the microbes that naturally colonize their intestines. To determine the association between immunostimulation and protection from persistent colonization in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Our study population will be comprised of children born at Pennsylvania Hospital between 2016-2018 and subsequently, followed in the Children's Hospital of Philadelphia (CHOP) Care Network or one of four other local primary care pediatric practices.
Key inclusion criteria (6 listed)
- Born at Pennsylvania Hospital
- Recruited at <120 hours of age
- Born at ≥36 0/7 weeks gestation
- Birth weight ≥2000 grams
- Parents plan to receive well-child care in the Children's Hospital of Philadelphia (CHOP) network, Society Hill Pediatrics, Center City Pediatrics, Penn Medicine or South Philly Pediatrics
Key exclusion criteria (6 listed)
- Child in neonatal intensive care unit (NICU) for >120 cumulative hours
- Biological mother NOT legal guardian, except surrogacy where guardianship is transferred at birth
- Biological mother NOT primary caretaker, except surrogacy where guardianship is transferred at birth
- Biological mother < 18 years of age
- Child has culture confirmed (blood or cerebrospinal fluid cultures) infection
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
cumulative microbial diversity
Time frame: 24 months
weight trajectory adjusted for time varying length
Time frame: 24 months
7 secondary outcomes
total number of individual bacterial taxa
Time frame: 24 months
expression levels of bacterial gene categories
Time frame: 24 months
fat stores in the upper arm/extremity
Time frame: 24 months
fat stores in the upper back/trunk
Time frame: 24 months
supine length trajectory
Time frame: 24 months
determine the association between immunostimulation and protection from persistent colonization in humans
Time frame: 24 months
Use autologous serum antibodies to "tag" fecal microbes
Time frame: 24 months
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 12 Jan 2024.
- Official study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data will be shared with collaborators at the Knights Lab at the University of Minnesota.
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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.
Jeffrey S Gerber, MD, PhD principal investigator
Children's Hospital of Philadelphia
Dan Knights, PhD principal investigator
University of Minnesota
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 Obesity, Childhood and Antibiotic Side Effect, run by Children's Hospital of Philadelphia 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 6 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 12 Jan 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 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?
cumulative microbial diversity (time frame: 24 months). The study lists 2 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 12 Jan 2024.