Infant Diet and Caregiver Resistome (IDCR)

June 26, 2026 updated by: University of Florida

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks from enrollment
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
2 weeks from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count and diversity of antimicrobial resistance genes (ARGs) and caregiver diet
Time Frame: 2 weeks from enrollment
We will also test for the extent caregiver diet impacts their own carriage of ARGs
2 weeks from enrollment
Diversity and abundance of antimicrobial resistance genes (ARGs) and interactions
Time Frame: 2 weeks
Determine the extent to which caregiver type of interaction (e.g. diaper changes, cuddling infants) impacts caregiver ARGs
2 weeks
Caregiver gut microbiome
Time Frame: 2 weeks
Determine the extent to which infant diet, caregiver diet, and infant-caregiver interactions impact the caregiver gut microbiome.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

August 19, 2027

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB202600912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Professional Caregivers Working With Infants Under Age 6 Months

Clinical Trials on None. Observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe