HealthyPoobiomeNCT05847543
Building an AI to Infer/Predict an Estimated Stool Microbiome Profile
An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 4 sites in 3 countries.
Trial summary
This is a study to collect data to build, evaluate and validate (test) a tool to infer/predict an estimated microbiome (community of microorganisms such as bacteria, fungi and viruses that exists in a particular environment) profile. Read more about this study
- Who is it for?
- Ages 0 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Stool diaper data and sample collection
- How many people
- 440 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Mar 2023to 22 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy term children aged 0 to 18 months old
Who may be able to join
- Children aged from 0 to 18 months old
- Parent(s) should have access to the internet and a smartphone or tablet to upload stool data and complete the study questionnaires in the OneBiome web-platform.
- Parent(s) should be able to comprehend the content of the study and to complete the study procedures in English.
- Written consent from parent.
Who cannot join
- Parent(s) incapable of completing the study questionnaires and uploading of the stool data using smart phone or tablet with internet.
- Children born before gestational age 37 weeks.
- Any other family member is enrolled in the study
- Incapability of parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Singapore2 sites
Mount Elizabeth Medical Centre
Singapore, 228510
KK Women's and Children's Hospital
Singapore, 229899
About this study
Official title: A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile
This is a study to collect data to build, evaluate and validate (test) a tool to infer/predict an estimated microbiome (community of microorganisms such as bacteria, fungi and viruses that exists in a particular environment) profile. The study will take place at several hospitals/clinics across Singapore, Malaysia, and Thailand.
- Conditions
- Healthy
- Being tested
- Stool diaper data and sample collection
- Keywords
- Microbiome, Artificial Intelligence, Stool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool diaper data and sample collectionOther
Stool diaper data and sample collection
| Study group | Role | What they receive |
|---|---|---|
| Non-weaned Children | Children who have not started weaning food Receives: Other: Stool diaper data and sample collection | |
| Weaned Children (Non-Caucasian) | Non-Caucasian children who have started weaning food Receives: Other: Stool diaper data and sample collection | |
| Weaned Children (Caucasian) | Caucasian children who have started weaning food Receives: Other: Stool diaper data and sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis
To collect stool data and stool samples for full microbiome analysis.
To collect stool images, stool data and stool samples for full microbiome analysis
Measured: 7 days
Secondary outcomes (3)
To assess the microbiome composition in the stool sample of the subject
To assess the microbiome composition in the stool sample of the subject
Measured: 7 days
To assess the dietary pattern based on Food Frequency Questionnaire (FFQ)
To determine/assess the eating/dietary pattern of the participants based on the Food Frequency Questionnaire (FFQ) data and reflect insights in the OneBiome report
Measured: 7 days
To explore the association between microbiome composition and known factors that influence the microbiome in early life
To explore the association between microbiome composition and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Mar 2023
- Primary completion28 Sep 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cross-sectional
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KK Women's and Children's Hospital, National University Hospital, Singapore, University of Malaya, Thammasat University Hospital, Mount Elizabeth Medical Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847543
- Sponsor's protocol ID
- EBB19GC16961-A
- Acronym
- Poobiome
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2023
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile
- ClinicalTrials.gov ID
- NCT05847543
- Acronym / sponsor ID
- Poobiome / EBB19GC16961-A
- Conditions
- Healthy
- Keywords
- Microbiome, Artificial Intelligence, Stool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KK Women's and Children's Hospital, National University Hospital, Singapore, University of Malaya, Thammasat University Hospital, Mount Elizabeth Medical Centre
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 6 May 2023 (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.
This is a study to collect data to build, evaluate and validate (test) a tool to infer/predict an estimated microbiome (community of microorganisms such as bacteria, fungi and viruses that exists in a particular environment) profile. The study will take place at several hospitals/clinics across Singapore, Malaysia, and Thailand.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-weaned Children | – | Other: Stool diaper data and sample collectionChildren who have not started weaning food |
| Weaned Children (Non-Caucasian) | – | Other: Stool diaper data and sample collectionNon-Caucasian children who have started weaning food |
| Weaned Children (Caucasian) | – | Other: Stool diaper data and sample collectionCaucasian children who have started weaning food |
Who may qualify
- Ages
- 0 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy term children aged 0 to 18 months old
Key inclusion criteria (4 listed)
- Children aged from 0 to 18 months old
- Parent(s) should have access to the internet and a smartphone or tablet to upload stool data and complete the study questionnaires in the OneBiome web-platform.
- Parent(s) should be able to comprehend the content of the study and to complete the study procedures in English.
- Written consent from parent.
Key exclusion criteria (4 listed)
- Parent(s) incapable of completing the study questionnaires and uploading of the stool data using smart phone or tablet with internet.
- Children born before gestational age 37 weeks.
- Any other family member is enrolled in the study
- Incapability of parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool diaper data and sample collectionStool diaper data and sample collection | Other | Non-weaned Children, Weaned Children (Caucasian), Weaned Children (Non-Caucasian) |
Primary outcome
To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis
Time frame: 7 days
To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis
3 secondary outcomes
To assess the microbiome composition in the stool sample of the subject
Time frame: 7 days
To assess the dietary pattern based on Food Frequency Questionnaire (FFQ)
Time frame: 7 days
To explore the association between microbiome composition and known factors that influence the microbiome in early life
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 4 sites in 3 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore, Malaysia, Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis (time frame: 7 days). 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 6 Feb 2025.