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

Completed

• Conditions: Healthy
• Interventions: Other: Stool diaper data and sample collection

• Registration Number: NCT05847543
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-21
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-06
• Primary Completion: 2024-09-28
• Study Completion: 2024-12-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-weaned Children	Stool diaper data and sample collection	Children who have not started weaning food
Weaned Children (Non-Caucasian)	Stool diaper data and sample collection	Non-Caucasian children who have started weaning food
Weaned Children (Caucasian)	Stool diaper data and sample collection	Caucasian children who have started weaning food

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

University Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia

Mount Elizabeth Medical Centre; 🇸🇬 Singapore, Singapore

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

Thammasat University Hospital; 🇹🇭 Pathumthani, Thailand