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NCT05472688 Clinical Trial

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

Dysbiosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05472688
Other study ID # PB-2022-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 14, 2022
Est. completion date December 31, 2029

Study information
Verified date April 2024
Source Persephone Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 430
Est. completion date December 31, 2029
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Months to 2 Months
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Persephone Biosciences, Inc. San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Persephone Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the composition of a healthy infant microbiome 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. 6-12 Months
Secondary Evaluate impact of the microbiome on immune adverse events 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) 7 Years
Secondary Build a library of samples and data for future research Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata. 6-12 Months
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