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

Healthy Clinical Trial

— Poobiome  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847543
• Other study ID #: EBB19GC16961-A
• Status: Recruiting
• Start date: March 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: Jill Wong, MSc
• Phone: +65 8228 1172
• Email: jill.wong[@]danone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Stool diaper data and sample collection
Stool diaper data and sample collection

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Center	Kuala Lumpur
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	Mount Elizabeth Medical Centre	Singapore
Singapore	National University Hospital, Singapore	Singapore
Thailand	Thammasat University Hospital	Pathumthani

Sponsors (6)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.	KK Women's and Children's Hospital, Mount Elizabeth Medical Centre, National University Hospital, Singapore, Thammasat University Hospital, University of Malaya

Countries where clinical trial is conducted

Malaysia,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents	The accuracy level of the stool AI in predicting the stool consistency using BITSS 4-point scale versus the scores provided by parents on the same 4-point scale	7 days
Primary	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	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
Secondary	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
Secondary	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