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

NCT ID: NCT05472688

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-14

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysbiosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Persephone Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Persephone Biosciences, Inc.

San Diego, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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PB-2022-01

Identifier Type: -

Identifier Source: org_study_id

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