My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05472688

Enrollment

430

Registered

2022-07-25

Start date

2022-07-14

Completion date

2029-12-31

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysbiosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Months to 2 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Determine the composition of a healthy infant microbiome	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

Measure	Time frame	Description
Evaluate impact of the microbiome on immune adverse events	7 Years	Metadata from questionnaires regarding child immune health will be correlated with the metagenomic gut microbiome composition obtained from the stool sample to define the impact of individual strains on immune adverse events (i.e. allergies, diabetes, asthma, eczema)
Build a library of samples and data for future research	6-12 Months	Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.

Countries

United States

Outcome results