Infant Diet and Caregiver Resistome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: None. Observational study.
- Who it may be relevant to
- Registry conditions: Professional Caregivers Working With Infants Under Age 6 Months. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breastfeeding and Its Impact on the Infant-caregiver Resistome
Overview
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.
Interventions
- Other None. Observational study
We will collect stool samples and questionnaires on infant caregivers
Primary outcome measures
- Count of antimicrobial resistance genes (ARGs) in stool [Time frame: 2 weeks from enrollment]
- Abundance of antimicrobial resistance genes (ARGs) [Time frame: 2 weeks from enrollment]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07680972 · IRB202600912