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

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 Overview

• Status: Active, not recruiting
• Conditions: Dysbiosis

• Study Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Persephone Biosciences, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 months (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

It is anticipated that 600 infants will enroll in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent. Additionally, we will look to maintain a demographic that represents different birth and feeding modes.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Persephone Biosciences

Publications and helpful links

Helpful Links

• Persephone Biosciences Website

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Dysbiosis
• Other Study ID Numbers: PB-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No