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Infant Diet and Caregiver Resistome

ConditionProfessional Caregivers Working With Infants Under Age 6 Months
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • None. Observational study

    Other intervention

    We will collect stool samples and questionnaires on infant caregivers

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Count of antimicrobial resistance genes (ARGs) in stool

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

Time frame
2 weeks from enrollment
2

Abundance of antimicrobial resistance genes (ARGs)

Abundance of ARGs in stool samples from caregivers in relation to infant usual feeding practices

Time frame
2 weeks from enrollment

Secondary outcomes

1

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

Time frame
2 weeks from enrollment
2

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

Time frame
2 weeks
3

Caregiver gut microbiome

Determine the extent to which infant diet, caregiver diet, and infant-caregiver interactions impact the caregiver gut microbiome.

Time frame
2 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: