Professional Caregivers Working With Infants Under Age 6 MonthsIDCRNCT07680972
Infant Diet and Caregiver Resistome
An observational study of Professional Caregivers Working With Infants Under Age 6 Months, run by University of Florida.
Trial summary
Antimicrobial resistance genes (ARGs) are the genes that allow bacteria to survive antibiotic treatments. These genes can be found in beneficial gut microbes, and occur more frequently in infants than adults. These genes can also transmit between different bacterial species. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Professional Caregivers Working With Infants Under Age 6 Months
- What is being tested?
- None. Observational study
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 31 May 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Professional infant caregivers who work with infants at least 3 days a week for at least 6 hours per day who meet the inclusion and exclusion criteria of the sample.
Who may be able to join
- Employment at a childcare facility or home daycare at time of sampling
- Participant works and interacts with infants under the age 6 months old, including responsibility for changing diapers
- Participant >18 years old
Who cannot join
- Participant has a history or presence of a medical condition including Ulcerative Colitis, Crohn's Disase, Inflammatory Bowel Disease, colon cancer, Celiac's disease, or other GI disordrs
- Current priobitic use or probiotic use within the last 4 weeks
- Participant is currently pregnant or breastfeeding
- Participant has an infant <12 months old at home for 3 or more days per week
- Enrollment in a clinical trial involving an invstigational drug or dvic
- Antibiotic use within the past 3 months
- Participant working exclusively with infants >6 months old at time of stool sample collection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dylan KP Blaufus, MS contact
About this study
Official title: Breastfeeding and Its Impact on the Infant-caregiver Resistome
Antimicrobial resistance genes (ARGs) are the genes that allow bacteria to survive antibiotic treatments. These genes can be found in beneficial gut microbes, and occur more frequently in infants than adults. These genes can also transmit between different bacterial species. Exclusively breastfed infants carry fewer ARGs than formula fed infants. We are trying to find out if care-givers working with exclusively breastfed infants have fewer ARGs than those working with formula fed infants.
- Being tested
- None. Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None. Observational studyOther
We will collect stool samples and questionnaires on infant caregivers
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of antimicrobial resistance genes (ARGs) in stool
Count of ARGs in stool sample, and association with infant usual diet
Measured: 2 weeks from enrollment
Abundance of antimicrobial resistance genes (ARGs)
Abundance of ARGs in stool samples from caregivers in relation to infant usual feeding practices
Measured: 2 weeks from enrollment
Secondary outcomes (3)
Count and diversity of antimicrobial resistance genes (ARGs) and caregiver diet
We will also test for the extent caregiver diet impacts their own carriage of ARGs
Measured: 2 weeks from enrollment
Diversity and abundance of antimicrobial resistance genes (ARGs) and interactions
Determine the extent to which caregiver type of interaction (e.g. diaper changes, cuddling infants) impacts caregiver ARGs
Measured: 2 weeks
Caregiver gut microbiome
Determine the extent to which infant diet, caregiver diet, and infant-caregiver interactions impact the caregiver gut microbiome.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start20 Aug 2026 (estimated)
- Primary completion19 Aug 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Professional Caregivers Working With Infants Under Age 6 MonthsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680972
- Sponsor's protocol ID
- IRB202600912
- Acronym
- IDCR
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to post the host-subtracted metagenomic sequencing data in SRA or other biorepository. We will share the de-identified metadata used in analysis as supplements to any publications.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding and Its Impact on the Infant-caregiver Resistome
- ClinicalTrials.gov ID
- NCT07680972
- Acronym / sponsor ID
- IDCR / IRB202600912
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 19 Aug 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 2 Jul 2026 (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.
Antimicrobial resistance genes (ARGs) are the genes that allow bacteria to survive antibiotic treatments. These genes can be found in beneficial gut microbes, and occur more frequently in infants than adults. These genes can also transmit between different bacterial species. Exclusively breastfed infants carry fewer ARGs than formula fed infants. We are trying to find out if care-givers working with exclusively breastfed infants have fewer ARGs than those working with formula fed infants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Professional infant caregivers who work with infants at least 3 days a week for at least 6 hours per day who meet the inclusion and exclusion criteria of the sample.
Key inclusion criteria (3 listed)
- Employment at a childcare facility or home daycare at time of sampling
- Participant works and interacts with infants under the age 6 months old, including responsibility for changing diapers
- Participant >18 years old
Key exclusion criteria (7 listed)
- Participant has a history or presence of a medical condition including Ulcerative Colitis, Crohn's Disase, Inflammatory Bowel Disease, colon cancer, Celiac's disease, or other GI disordrs
- Current priobitic use or probiotic use within the last 4 weeks
- Participant is currently pregnant or breastfeeding
- Participant has an infant <12 months old at home for 3 or more days per week
- Enrollment in a clinical trial involving an invstigational drug or dvic
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 |
|---|---|---|
| None. Observational studyWe will collect stool samples and questionnaires on infant caregivers | Other | – |
Primary outcome
Count of antimicrobial resistance genes (ARGs) in stool
Time frame: 2 weeks from enrollment
Count of ARGs in stool sample, and association with infant usual diet
Abundance of antimicrobial resistance genes (ARGs)
Time frame: 2 weeks from enrollment
Abundance of ARGs in stool samples from caregivers in relation to infant usual feeding practices
3 secondary outcomes
Count and diversity of antimicrobial resistance genes (ARGs) and caregiver diet
Time frame: 2 weeks from enrollment
Diversity and abundance of antimicrobial resistance genes (ARGs) and interactions
Time frame: 2 weeks
Caregiver gut microbiome
Time frame: 2 weeks
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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. We plan to post the host-subtracted metagenomic sequencing data in SRA or other biorepository. We will share the de-identified metadata used in analysis as supplements to any publications.
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.
Dylan KP Blaufus, MS contact
Questions about this trial
What is this clinical trial studying?
An observational study of Professional Caregivers Working With Infants Under Age 6 Months, run by University of Florida.
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 3 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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?
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 Diana H Taft, PhD (352-294-3755, dianataft@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of antimicrobial resistance genes (ARGs) in stool (time frame: 2 weeks from enrollment). 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 2 Jul 2026.