DysbiosisNCT05472688
My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
An observational study of Dysbiosis, run by Persephone Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 31 Dec 2029
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Persephone Biosciences, Inc.
San Diego, California, 92121
About this study
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.
- Conditions
- Dysbiosis
- Medical subject headings
- Dysbiosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 Months
Secondary outcomes (2)
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)
Measured: 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.
Measured: 6-12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start14 Jul 2022
- Primary completion31 Mar 2023
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Persephone Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472688
- Sponsor's protocol ID
- PB-2022-01
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
- ClinicalTrials.gov ID
- NCT05472688
- Acronym / sponsor ID
- PB-2022-01
- Conditions
- Dysbiosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Persephone BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 0 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Evaluate impact of the microbiome on immune adverse events
Time frame: 7 Years
Build a library of samples and data for future research
Time frame: 6-12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Persephone Biosciences WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbiosis, run by Persephone Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the composition of a healthy infant microbiome (time frame: 6-12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.