My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
1 other identifier
observational
430
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2022
CompletedFirst Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedApril 5, 2024
April 1, 2024
9 months
July 20, 2022
April 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Evaluate impact of the microbiome on immune adverse events
7 Years
Build a library of samples and data for future research
6-12 Months
Eligibility Criteria
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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Persephone Biosciences, Inc.
San Diego, California, 92121, United States
Related Links
Biospecimen
We will be collecting infant fecal samples that we will be retaining. We will only be processing microbial DNA found in the fecal samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 25, 2022
Study Start
July 14, 2022
Primary Completion
March 31, 2023
Study Completion (Estimated)
December 31, 2029
Last Updated
April 5, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share