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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.
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| 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 |
| 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 |
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Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Persephone Biosciences, Inc. | San Diego | California | 92121 | United States |
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| Label | URL |
|---|---|
| Persephone Biosciences Website | View source |
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| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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We will be collecting infant fecal samples that we will be retaining. We will only be processing microbial DNA found in the fecal samples.
| 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 |