Infant Immunity Response and Immunoglobulin DiversityNCT02568579
Infant Immunity Comparison of Breastfed and Bottlefed Infants
An observational study of Infant Immunity Response and Immunoglobulin Diversity, run by Duke University at 3 sites in United States.
Trial summary
This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Immunity Response and Immunoglobulin Diversity
- What is being tested?
- blood sample/ stool sample
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to Dec 2017
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Pregnant women 18 years of age or older. * Vaginal delivery * Healthy, full-term babies. * Willing to primarily (> 75%) breastfeed or exclusively formula feed for at least the first 4 months of life. * Willing to follow the American Academy of Pediatrics' Immunizations guidelines.
Who may be able to join
- Self-declared pregnant woman
- Age 18 years or older at the time of consent
- Willing and able to sign consent and follow study schedule
- Planned vaginal delivery
- Willing to primarily breastfed or formula feed for the first four months
Who cannot join
- Planned delivery by C-Section
- Unwillingness to exclusively breast feed or formula feed their infant for at least the first 4 months
- Unwillingness to receive standard immunizations on the schedule recommended by the American Academy of Pediatrics
- Chronic maternal condition that may influence infant immunity including but not limited to: maternal HIV, immunodeficiency, use of immunosuppressive medications, malignancy or autoimmunity
- Known fetal medical conditions such as congenital malformations
- Use of immune modulating/immune suppressive medication and prophylactic antibiotics during pregnancy
- Any condition that may prevent a mother who plans to breast feed from breast feeding
- Any condition that in the opinion of the investigator would interfere with the conduct of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UNC Chapel Hill
Chapel Hill, North Carolina, 27514
Duke University Medical Center
Durham, North Carolina, 27710
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Effects of Breastfeeding in Immunologic Priming in Young Infants
This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact via phone/email to collect information about feeding changes.
Read the detailed description
Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6 month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12 months of age prior to their 12 month immunization. Additionally, stool samples will be collected within the first week of live and once monthly through 12 months of age. Breastfeeding mothers will collect breast milk once monthly at the same time as the stool specimen during the period of breastfeeding.
- Being tested
- blood sample/ stool sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample/ stool sampleProcedure or surgery
blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
| Study group | Role | What they receive |
|---|---|---|
| Breastfed | collection of blood/stool/breast milk samples and information about feeding changes and introduction of solid foods. - Cord Blood sample, stool samples monthly and blood sample at 6 month and 12 months of age Receives: Procedure: blood sample/ stool sample | |
| Bottlefed | collection of blood/stool samples and information about feeding changes and introduction of solid foods. Coord blood sample, stool samples monthly and blood sample at 6 month and 12 month of age. Receives: Procedure: blood sample/ stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profile of human IgG and IgA by pyrosequencing.
B cell priming and immunoglobulin diversity following immunizations at 2 and 4 month of age by modulating the microbial colonization of infant gut by pyrosequencing by using isotype specific primers.
Measured: 12 months
Secondary outcomes (3)
Vaccine response
post immunization antibody titers (via ELISA) to Hib, tetanus, diphtheria, pertussis and pneumococcal polysaccharide serotypes contained in the Prevnar 13 vaccine.
Measured: 12 months
Antibody activity
Functional activity of antibodies measured by opsonophagocytic activity to Pneumococcal and Hib vaccine
Measured: 12 months
Plasma level of B cell activating factor and/or a proliferation-inducing ligand
Degree of B cell differentiation and activation in B cell by BD bioscience Canto flow cytometry.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionDec 2017
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 Infant Immunity Response and Immunoglobulin DiversityStudies of the same condition, open and under way.
- More trials run by Duke 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, Children's Hospital Los Angeles
- Responsible party
- Sponsor
- Investigators
- John Sleasman, MD, Study director, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568579
- Sponsor's protocol ID
- Pro00050219
- Status last verified
- Jun 2017
- First submitted
- 15 Sep 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Yin L, Venturi GM, Barfield R, Fischer BM, Kim-Chang JJ, Chan C, De Paris K, Goodenow MM, Sleasman JW. Maternal immunity shapes biomarkers of germinal center development in HIV-exposed uninfected infants. Front Immunol. 2024 Sep 12;15:1443886. doi: 10.3389/fimmu.2024.1443886. eCollection 2024.
PubMed 39328414
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breastfeeding in Immunologic Priming in Young Infants
- ClinicalTrials.gov ID
- NCT02568579
- Acronym / sponsor ID
- Pro00050219
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of South Florida, Children's Hospital Los Angeles
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Oct 2015 (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 study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact via phone/email to collect information about feeding changes.
Detailed description
Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6 month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12 months of age prior to their 12 month immunization. Additionally, stool samples will be collected within the first week of live and once monthly through 12 months of age. Breastfeeding mothers will collect breast milk once monthly at the same time as the stool specimen during the period of breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfed | – | Procedure: blood sample/ stool samplecollection of blood/stool/breast milk samples and information about feeding changes and introduction of solid foods. - Cord Blood sample, stool samples monthly and blood sample at 6 month and 12 months of age |
| Bottlefed | – | Procedure: blood sample/ stool samplecollection of blood/stool samples and information about feeding changes and introduction of solid foods. Coord blood sample, stool samples monthly and blood sample at 6 month and 12 month of age. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Pregnant women 18 years of age or older. * Vaginal delivery * Healthy, full-term babies. * Willing to primarily (> 75%) breastfeed or exclusively formula feed for at least the first 4 months of life. * Willing to follow the American Academy of Pediatrics' Immunizations guidelines.
Key inclusion criteria (5 listed)
- Self-declared pregnant woman
- Age 18 years or older at the time of consent
- Willing and able to sign consent and follow study schedule
- Planned vaginal delivery
- Willing to primarily breastfed or formula feed for the first four months
Key exclusion criteria (8 listed)
- Planned delivery by C-Section
- Unwillingness to exclusively breast feed or formula feed their infant for at least the first 4 months
- Unwillingness to receive standard immunizations on the schedule recommended by the American Academy of Pediatrics
- Chronic maternal condition that may influence infant immunity including but not limited to: maternal HIV, immunodeficiency, use of immunosuppressive medications, malignancy or autoimmunity
- Known fetal medical conditions such as congenital malformations
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 |
|---|---|---|
| blood sample/ stool sampleblood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home. | Procedure or surgery | Bottlefed, Breastfed |
Primary outcome
Molecular profile of human IgG and IgA by pyrosequencing.
Time frame: 12 months
B cell priming and immunoglobulin diversity following immunizations at 2 and 4 month of age by modulating the microbial colonization of infant gut by pyrosequencing by using isotype specific primers.
3 secondary outcomes
Vaccine response
Time frame: 12 months
Antibody activity
Time frame: 12 months
Plasma level of B cell activating factor and/or a proliferation-inducing ligand
Time frame: 12 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 29 Jan 2018.
- Derived from this study: PubMed 39328414Yin L, Venturi GM, Barfield R, Fischer BM, Kim-Chang JJ, Chan C, De Paris K, Goodenow MM, Sleasman JW. Maternal immunity shapes biomarkers of germinal center development in HIV-exposed uninfected infants. Front Immunol. 2024 Sep 12;15:1443886. doi: 10.3389/fimmu.2024.1443886. eCollection 2024.
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.
John Sleasman, MD study director
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Immunity Response and Immunoglobulin Diversity, run by Duke University at 3 sites 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 5 inclusion and 8 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Molecular profile of human IgG and IgA by pyrosequencing. (time frame: 12 months). 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 NCT02568579, 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 29 Jan 2018.