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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dysbiosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 month–2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Persephone Biosciences, Inc.

San Diego, California, 92121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Determine the composition of a healthy infant microbiome

Time frame: 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 outcomes

Evaluate impact of the microbiome on immune adverse events

Time frame: 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)
Build a library of samples and data for future research

Time frame: 6-12 Months

Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.

Sponsors and collaborators

Lead sponsor

Persephone Biosciences

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2029
First posted: Jul 25, 2022
Registry last updated: Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting