NCT05847543

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

April 27, 2023

Last Update Submit

February 5, 2025

Conditions

Healthy

Keywords

MicrobiomeArtificial IntelligenceStool

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

    7 days

  • To explore the association between microbiome composition and known factors that influence the microbiome in early life

    7 days

Other Outcomes (1)

  • The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents

    7 days

Study Arms (3)

Non-weaned Children

Children who have not started weaning food

Other: 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

Weaned Children (Caucasian)

Caucasian children who have started weaning food

Other: Stool diaper data and sample collection

Interventions

Stool diaper data and sample collectionOTHER

Stool diaper data and sample collection

Non-weaned ChildrenWeaned Children (Caucasian)Weaned Children (Non-Caucasian)

Eligibility Criteria

Age0 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy term children aged 0 to 18 months old

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Mount Elizabeth Medical Centre

Singapore, 228510, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 6, 2023

Study Start

March 21, 2023

Primary Completion

September 28, 2024

Study Completion

December 22, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)SG(2)TH(1)