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

Active, not recruiting

• Conditions: Dysbiosis

• Registration Number: NCT05472688
• Lead Sponsor: Persephone Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Primary Completion: 2023-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 430

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Persephone Biosciences, Inc.; 🇺🇸 San Diego, California, United States