ObesityABXNCT02744846
Short- and Long-Term Effects of Antibiotics on Childhood Growth
An observational study of Obesity, run by Harvard Pilgrim Health Care.
Trial summary
The objectives of the proposed study are to assess the effects of different types, timing, and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to age 5 years. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Obesity
- What is being tested?
- Antibiotics exposure
- How many people
- 681,739 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include children from age 0 to age 11 years. The population will be identified using data from participating sites formatted into the PCORnet Common Data Model (CDM).
Who may be able to join
- 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 months, 12-30 months, and
- 1 or more encounters with height and weight measured after 24 months of age (need 1 or more measure at 4.0-5.9 years for the 5 year outcome and 1 or more measure at 9.0 to 10.9 years for the 10 year outcome), or eligible to be followed to these ages using multiple imputation to account for missing data.
Who cannot join
- 1. Biologically implausible length/height or weight measurements
About this study
Official title: The Patient-Centered Outcomes Research Network (PCORnet) Obesity Observational Study: Short- and Long-Term Effects of Antibiotics on Childhood Growth
The objectives of the proposed study are to assess the effects of different types, timing, and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to age 5 years. In Specific Aim 3, the investigators will address how big the effects of antibiotics on obesity are within subgroups of the population, such as different racial/ethnic groups and whether the child's mother got antibiotics while she was pregnant.
The data for this study will come from electronic medical records of about 600,000 children from 42 healthcare systems within 10 Clinical Data Research Networks (CDRNs) across the United States. The investigators will get information on antibiotic prescribing in the first two years of life, then "virtually" follow these children to ages 5 and 10 years to see what their BMIs are, and how many of them are obese by clinical standards (i.e., body mass index exceeding the 95th percentile for age and sex).
Read more
In the main analyses, the CDRNs will not send any individual data to a central site. Rather, using sophisticated computer programs, the study's coordinating center will send "questions to the data," thus protecting the privacy of patients' and the healthcare systems' records. In some analyses, to check how well this "distributed research network" approach works, we will work with individual records whose identifying information has been stripped off ("de-identified data").
In our Secondary Aim, the investigators will employ focus groups of parents and in-depth interviews with clinicians to explore how best to put the findings into everyday practice.
Throughout the study, in addition to employing privacy-protecting approaches to analyzing and sharing data, the investigators will adhere to principles of inclusion, patient-centeredness, stakeholder engagement, effective governance, and protection of human subjects. At the end of the two-year project, the investigators will propose avenues for dissemination of the scientific findings and other products.
Read the detailed description
Antibiotics are among the most valuable medical discoveries. Recent research on understanding of how bacteria in our gut use energy, however, raises concerns about whether broad-spectrum antibiotics, which are over-prescribed for mild infections, prescribed in early infancy may cause obesity during childhood. Obesity is a very common and serious condition among US children, particularly children from disadvantaged populations. Past studies examining the link between antibiotic use and childhood obesity are too small and they lack diversity as well as modern scientific tools to gauge the extent to which prescribing antibiotics can lead to excess weight gain. PCORnet, the National Patient-Centered Clinical Research Network, comprising very large networks of data from electronic medical records, provides an ideal test bed to address this question. Further, it is not clear how caregivers and clinicians will use the results of earlier studies to decide which antibiotics to prescribe when faced with common infections like ear infections.
Specific Aim 1: To evaluate the comparative effects of different types, timing, and amount of antibiotics used during the first two years of life on body mass index and risk of obesity at ages 5 (primary outcome age) and 10 (secondary) years. Hypothesis: There will be a "dose-response" relationship between the number of antibiotic courses given during the first 2 years of life and both higher BMI and the probability of obesity at ages 5 and 10 years. This relationship will be strongest for broad-spectrum antibiotics prescribed in the first 6 months of life.
Specific Aim 2: To assess the comparative effects of different types, timing, and amount of antibiotics used during the first two years of life on the rates and patterns of childhood growth during the first 5 years of life. Hypothesis: There will be a "dose-response" relationship between the number of antibiotic courses given during the first 2 years of life and subsequent growth trajectories of children in a pattern that increases children's risk of later overweight and obesity. This relationship will be strongest for broad-spectrum antibiotics prescribed in the first 6 months of life.
Specific Aim 3: To explore how the effects of different types, timing, and amount of antibiotics on childhood BMI, obesity risk and growth (Aims 1 and 2) vary according to patient socio-demographic, clinical, and maternal characteristics, including: 1) socio-demographic (Child sex, Child race/ethnicity, Geography, based on location of clinical facility); 2) Clinical (Prescription of medications that also cause obesity, esp. corticosteroids, Low birth weight or macrosomia in term infants); 3) Maternal for the subset of data partners listed in section B above that have linked maternal and child records (BMI, Maternal receipt of antibiotics during pregnancy, Type of delivery, i.e., Cesarean v. vaginal). Hypotheses: The antibiotic effects will not vary by socio-demographic or maternal characteristics. Long-term corticosteroid use will potentiate the effect of antibiotics on childhood obesity.
Secondary Aim: Through focus groups and in-depth interviews, to explore how parents and other caregivers and their providers assess information related to current and future benefits and risks, particularly for treatments such as antibiotics in early childhood, which can have substantial near-term benefits along with moderate long-term risks. The investigators will also explore how clinicians, health care organizations, and policy makers should best present study findings to help parents understand its strengths and limitations in the context of shared clinical decision-making.
- Conditions
- Obesity
- Being tested
- Antibiotics exposure
- Keywords
- antibiotics, children, pediatric, body mass index, Observational Study, Comparative Effectiveness Research, Obesity, Growth Trajectory, Cohort Study, Electronic Medical Record, Qualitative Research
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics exposureDrug
| Study group | Role | What they receive |
|---|---|---|
| Children from birth to 5 years | Children from birth to 5 years where:
1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and
2. > 1 encounter with height and weight measured in either or both of the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data Receives: Drug: Antibiotics exposure | |
| Children from birth to 10 years | Children from birth to 10 years where:
1. 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 m, 12-30 m, and
2. > 1 encounter with height and weight measured in the following age interval: 9.0 to 10.9 y ("age 10 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data. Receives: Drug: Antibiotics exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months
BMI z-score measured between 48-72 months Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Measured: 48-72 Months
Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months
BMI measured at 10 years Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Retrospective
- Enrolment
- 681,739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Patient-Centered Clinical Research Network, ADVANCE CDRN, Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), Greater Plains Collaborative Clinical Data Research Network, Mid-South Clinical Data Research Network, New York City Clinical Data Research Network, OneFlorida Clinical Research Consortium, PEDSnet: A Pediatric Learning Health System CDRN, PORTAL CDRN, Research Action for Health Network (REACHnet), Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS), Genetic Alliance, StatLog
- Responsible party
- Principal investigator, Jason Block, Harvard Pilgrim Health Care
- Investigators
- Jason P Block, MD, MPH, Principal investigator, Harvard Pilgrim Health Care InstituteChristopher B Forrest, MD, PhD, Principal investigator, Children's Hospital of PhiladelphiaDouglas Lunsford, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744846
- Sponsor's protocol ID
- OBS-1505-30699
- Acronym
- ABX
- Status last verified
- Dec 2019
- First submitted
- 13 Apr 2016
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared publicly per Patient-Centered Outcomes Research Institute (PCORI) regulations 12 months after study completion. De-identified individual level data and aggregate data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient-Centered Outcomes Research Network (PCORnet) Obesity Observational Study: Short- and Long-Term Effects of Antibiotics on Childhood Growth
- ClinicalTrials.gov ID
- NCT02744846
- Acronym / sponsor ID
- ABX / OBS-1505-30699
- Conditions
- Obesity
- Keywords
- antibiotics, children, pediatric, body mass index, Observational Study, Comparative Effectiveness Research, Obesity, Growth Trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 681,739 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Patient-Centered Clinical Research Network, ADVANCE CDRN, Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), Greater Plains Collaborative Clinical Data Research Network, Mid-South Clinical Data Research Network, New York City Clinical Data Research Network, OneFlorida Clinical Research Consortium, PEDSnet: A Pediatric Learning Health System CDRN, PORTAL CDRN, Research Action for Health Network (REACHnet), Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS), Genetic Alliance, StatLog
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 20 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the proposed study are to assess the effects of different types, timing, and amount of antibiotic use in the first two years of life with (Specific Aim 1) body mass index (BMI) and obesity at ages 5 and 10 years and (Specific Aim 2) growth trajectories to age 5 years. In Specific Aim 3, the investigators will address how big the effects of antibiotics on obesity are within subgroups of the population, such as different racial/ethnic groups and whether the child's mother got antibiotics while she was pregnant.
The data for this study will come from electronic medical records of about 600,000 children from 42 healthcare systems within 10 Clinical Data Research Networks (CDRNs) across the United States. The investigators will get information on antibiotic prescribing in the first two years of life, then "virtually" follow these children to ages 5 and 10 years to see what their BMIs are, and how many of them are obese by clinical standards (i.e., body mass index exceeding the 95th percentile for age and sex).
In the main analyses, the CDRNs will not send any individual data to a central site. Rather, using sophisticated computer programs, the study's coordinating center will send "questions to the data," thus protecting the privacy of patients' and the healthcare systems' records. In some analyses, to check how well this "distributed research network" approach works, we will work with individual records whose identifying information has been stripped off ("de-identified data").
In our Secondary Aim, the investigators will employ focus groups of parents and in-depth interviews with clinicians to explore how best to put the findings into everyday practice.
Throughout the study, in addition to employing privacy-protecting approaches to analyzing and sharing data, the investigators will adhere to principles of inclusion, patient-centeredness, stakeholder engagement, effective governance, and protection of human subjects. At the end of the two-year project, the investigators will propose avenues for dissemination of the scientific findings and other products.
Detailed description
Antibiotics are among the most valuable medical discoveries. Recent research on understanding of how bacteria in our gut use energy, however, raises concerns about whether broad-spectrum antibiotics, which are over-prescribed for mild infections, prescribed in early infancy may cause obesity during childhood. Obesity is a very common and serious condition among US children, particularly children from disadvantaged populations. Past studies examining the link between antibiotic use and childhood obesity are too small and they lack diversity as well as modern scientific tools to gauge the extent to which prescribing antibiotics can lead to excess weight gain. PCORnet, the National Patient-Centered Clinical Research Network, comprising very large networks of data from electronic medical records, provides an ideal test bed to address this question. Further, it is not clear how caregivers and clinicians will use the results of earlier studies to decide which antibiotics to prescribe when faced with common infections like ear infections.
Specific Aim 1: To evaluate the comparative effects of different types, timing, and amount of antibiotics used during the first two years of life on body mass index and risk of obesity at ages 5 (primary outcome age) and 10 (secondary) years. Hypothesis: There will be a "dose-response" relationship between the number of antibiotic courses given during the first 2 years of life and both higher BMI and the probability of obesity at ages 5 and 10 years. This relationship will be strongest for broad-spectrum antibiotics prescribed in the first 6 months of life.
Specific Aim 2: To assess the comparative effects of different types, timing, and amount of antibiotics used during the first two years of life on the rates and patterns of childhood growth during the first 5 years of life. Hypothesis: There will be a "dose-response" relationship between the number of antibiotic courses given during the first 2 years of life and subsequent growth trajectories of children in a pattern that increases children's risk of later overweight and obesity. This relationship will be strongest for broad-spectrum antibiotics prescribed in the first 6 months of life.
Specific Aim 3: To explore how the effects of different types, timing, and amount of antibiotics on childhood BMI, obesity risk and growth (Aims 1 and 2) vary according to patient socio-demographic, clinical, and maternal characteristics, including: 1) socio-demographic (Child sex, Child race/ethnicity, Geography, based on location of clinical facility); 2) Clinical (Prescription of medications that also cause obesity, esp. corticosteroids, Low birth weight or macrosomia in term infants); 3) Maternal for the subset of data partners listed in section B above that have linked maternal and child records (BMI, Maternal receipt of antibiotics during pregnancy, Type of delivery, i.e., Cesarean v. vaginal). Hypotheses: The antibiotic effects will not vary by socio-demographic or maternal characteristics. Long-term corticosteroid use will potentiate the effect of antibiotics on childhood obesity.
Secondary Aim: Through focus groups and in-depth interviews, to explore how parents and other caregivers and their providers assess information related to current and future benefits and risks, particularly for treatments such as antibiotics in early childhood, which can have substantial near-term benefits along with moderate long-term risks. The investigators will also explore how clinicians, health care organizations, and policy makers should best present study findings to help parents understand its strengths and limitations in the context of shared clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children from birth to 5 years | – | Drug: Antibiotics exposureChildren from birth to 5 years where: 1. 1 or more encounters with length and weight measured in the following age interval: 0-12 m, 12-30 m, and 2. > 1 encounter with height and weight measured in either or both of the following age intervals: 4.0 to 5.9 y ("age 5 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data |
| Children from birth to 10 years | – | Drug: Antibiotics exposureChildren from birth to 10 years where: 1. 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 m, 12-30 m, and 2. > 1 encounter with height and weight measured in the following age interval: 9.0 to 10.9 y ("age 10 years"), or eligible to be followed to these ages for use in multiple imputation to account for missing data. |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include children from age 0 to age 11 years. The population will be identified using data from participating sites formatted into the PCORnet Common Data Model (CDM).
Key inclusion criteria (2 listed)
- 1 or more encounters with length and weight measured in each of the following age intervals: 0-12 months, 12-30 months, and
- 1 or more encounters with height and weight measured after 24 months of age (need 1 or more measure at 4.0-5.9 years for the 5 year outcome and 1 or more measure at 9.0 to 10.9 years for the 10 year outcome), or eligible to be followed to these ages using multiple imputation to account for missing data.
Key exclusion criteria (1 listed)
- 1. Biologically implausible length/height or weight measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics exposure | Drug | Children from birth to 10 years, Children from birth to 5 years |
Primary outcome
Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months
Time frame: 48-72 Months
BMI z-score measured between 48-72 months Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months
Time frame: 10 years
BMI measured at 10 years Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared publicly per Patient-Centered Outcomes Research Institute (PCORI) regulations 12 months after study completion. De-identified individual level data and aggregate data will be shared.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Jason P Block, MD, MPH principal investigator
Harvard Pilgrim Health Care Institute
Christopher B Forrest, MD, PhD principal investigator
Children's Hospital of Philadelphia
Douglas Lunsford principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Harvard Pilgrim Health Care.
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 2 inclusion and 1 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months (time frame: 48-72 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 20 Dec 2019.