Infant Diet and Caregiver Resistome

NCT07680972 | Not Yet Recruiting

• 1 other identifier: IRB202600912
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Professional Caregivers Working With Infants Under Age 6 Months

Outcome Measures

Primary Outcomes (2)

• Count of antimicrobial resistance genes (ARGs) in stool

  Count of ARGs in stool sample, and association with infant usual diet

  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

  2 weeks from enrollment

Secondary Outcomes (3)

• Count and diversity of antimicrobial resistance genes (ARGs) and caregiver diet

  2 weeks from enrollment

• Diversity and abundance of antimicrobial resistance genes (ARGs) and interactions

  2 weeks

• Caregiver gut microbiome

  2 weeks

Interventions

None. Observational study OTHER

We will collect stool samples and questionnaires on infant caregivers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Central Study Contacts

Diana H Taft, PhD

CONTACT

352-294-3755; dianataft@ufl.edu

Dylan KP Blaufus, MS

CONTACT

dblaufus@ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): August 19, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06