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

Sponsor
Persephone Biosciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05472688
Collaborator
(none)
600
Enrollment
1
Location
89.6
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
    Actual Study Start Date :
    Jul 14, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2029

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Months to 2 Months
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Persephone Biosciences, Inc. San Diego California United States 92121

    Sponsors and Collaborators

    • Persephone Biosciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Persephone Biosciences
    ClinicalTrials.gov Identifier:
    NCT05472688
    Other Study ID Numbers:
    • PB-2022-01
    First Posted:
    Jul 25, 2022
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dysbiosis

    Study Results

    No Results Posted as of Jul 25, 2022