Building an AI to Infer/Predict an Estimated Stool Microbiome Profile

A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05847543

Acronym

Poobiome

Enrollment

440

Registered

2023-05-06

Start date

2023-03-21

Completion date

2024-12-22

Last updated

2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microbiome, Artificial Intelligence, Stool

Brief 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. The study will take place at several hospitals/clinics across Singapore, Malaysia, and Thailand.

Interventions

OTHERStool diaper data and sample collection

Stool diaper data and sample collection

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

0 Months to 18 Months

Healthy volunteers

Yes

Inclusion criteria

1. Children aged from 0 to 18 months old 2. 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. 3. Parent(s) should be able to comprehend the content of the study and to complete the study procedures in English. 4. Written consent from parent.

Exclusion criteria

1. Parent(s) incapable of completing the study questionnaires and uploading of the stool data using smart phone or tablet with internet. 2. Children born before gestational age 37 weeks. 3. Any other family member is enrolled in the study 4. 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.

Design outcomes

Primary

Measure	Time frame	Description
To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis	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

Secondary

Measure	Time frame	Description
To assess the microbiome composition in the stool sample of the subject	7 days	To assess the microbiome composition in the stool sample of the subject
To assess the dietary pattern based on Food Frequency Questionnaire (FFQ)	7 days	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
To explore the association between microbiome composition and known factors that influence the microbiome in early life	7 days	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

Other

Measure	Time frame	Description
The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents	7 days	The accuracy level of the stool AI in predicting the stool consistency using BITSS 4-point scale versus the scores provided by parents on the same 4-point scale

Countries

Malaysia, Singapore, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026