Building an AI to Infer/Predict an Estimated Stool Microbiome Profile (Poobiome)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Stool diaper data and sample collection

• Study Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Center
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore, 228510
    • Mount Elizabeth Medical Centre
• Thailand
  • Pathumthani, Thailand, 12120
    • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy term children aged 0 to 18 months old

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-weaned Children; Children who have not started weaning food	Other: Stool diaper data and sample collection; Stool diaper data and sample collection
Weaned Children (Non-Caucasian); Non-Caucasian children who have started weaning food	Other: Stool diaper data and sample collection; Stool diaper data and sample collection
Weaned Children (Caucasian); Caucasian children who have started weaning food	Other: Stool diaper data and sample collection; Stool diaper data and sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the microbiome composition in the stool sample of the subject	To assess the microbiome composition in the stool sample of the subject	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	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	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents	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	7 days

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: National University Hospital, Singapore; University of Malaya; KK Women's and Children's Hospital; Thammasat University Hospital; Mount Elizabeth Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): September 28, 2024
• Study Completion (Actual): December 22, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Artificial Intelligence; Stool
• Other Study ID Numbers: EBB19GC16961-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No