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

NCT ID: NCT05847543

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-21

Study Completion Date

2024-12-22

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Non-weaned Children

Children who have not started weaning food

Stool diaper data and sample collection

Intervention Type OTHER

Stool diaper data and sample collection

Weaned Children (Non-Caucasian)

Non-Caucasian children who have started weaning food

Stool diaper data and sample collection

Intervention Type OTHER

Stool diaper data and sample collection

Weaned Children (Caucasian)

Caucasian children who have started weaning food

Stool diaper data and sample collection

Intervention Type OTHER

Stool diaper data and sample collection

Interventions

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Stool diaper data and sample collection

Stool diaper data and sample collection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role collaborator

Thammasat University Hospital

OTHER

Sponsor Role collaborator

Mount Elizabeth Medical Centre

UNKNOWN

Sponsor Role collaborator

Danone Asia Pacific Holdings Pte, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Malaya Medical Center

Kuala Lumpur, , Malaysia

Site Status

Mount Elizabeth Medical Centre

Singapore, , Singapore

Site Status

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Thammasat University Hospital

Pathum Thani, , Thailand

Site Status

Countries

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Malaysia Singapore Thailand

Other Identifiers

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EBB19GC16961-A

Identifier Type: -

Identifier Source: org_study_id

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