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

Danone

Status: Completed

Conditions: Healthy

Treatments: Other: Stool diaper data and sample collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05847543

EBB19GC16961-A

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: All

Ages: Under 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

440 participants in 3 patient groups

Non-weaned Children

Description:

Children who have not started weaning food

Treatment:

Other: Stool diaper data and sample collection

Weaned Children (Non-Caucasian)

Description:

Non-Caucasian children who have started weaning food

Treatment:

Other: Stool diaper data and sample collection

Weaned Children (Caucasian)

Description:

Caucasian children who have started weaning food

Treatment:

Other: Stool diaper data and sample collection