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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Stool diaper data and sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-weaned Children<br>Children who have not started weaning food | Other: Stool diaper data and sample collection<br>* Stool diaper data and sample collection<br>|
| Weaned Children (Non-Caucasian)<br>Non-Caucasian children who have started weaning food | Other: Stool diaper data and sample collection<br>* Stool diaper data and sample collection<br>|
| Weaned Children (Caucasian)<br>Caucasian children who have started weaning food | Other: Stool diaper data and sample collection<br>* Stool diaper data and sample collection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Artificial Intelligence, Stool