My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 430
- Locations
- 1
- Primary Endpoint
- Determine the composition of a healthy infant microbiome
Study Overview
Brief Summary
My Baby Biome is an observational study that will use 600 infant stool samples to determine the biomarkers associated with a healthy infant gut. Biomarkers identified in this study will be used to develop precision probiotics and LBPs for improving infant gut health outcomes to the benefit of all infants. Parents will be asked to submit follow-up questionnaires regarding infant immune health to improve insights obtained from the data.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Months to 2 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Infants under 2 weeks or over 2 months old
- •Infants given any antibiotic or probiotic treatments
- •Infants delivered prematurely or admitted to the NICU outside of establishment of normal feeding
- •Infants with mothers under the age of 18
- •Infants with mothers known to have HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
Outcomes
Primary Outcomes
Determine the composition of a healthy infant microbiome
Time Frame: 6-12 Months
Stool samples will be analyzed for bacterial metagenomics, metabolomics, proteomics, and transcriptomics to define biomarkers (such as bacteria or proteins) that are correlated with healthy infants as defined by the accompanying questionnaire.
Secondary Outcomes
- Evaluate impact of the microbiome on immune adverse events(7 Years)
- Build a library of samples and data for future research(6-12 Months)