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

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05847543
• Collaborator: KK Women's and Children's Hospital (Other), National University Hospital, Singapore (Other), University of Malaya (Other), Thammasat University Hospital (Other), Mount Elizabeth Medical Centre (Other)
• Enrollment: 550
• Locations: 5
• Anticipated Duration (Months): 8.4
• Patients Per Site: 110
• Patients Per Site Per Month: 13.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Stool diaper data and sample collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 550 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile
• Actual Study Start Date: Mar 21, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Non-weaned Children Children who have not started weaning food	Other: Stool diaper data and sample collection; 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; Stool diaper data and sample collection
Weaned Children (Caucasian) Caucasian children who have started weaning food	Other: Stool diaper data and sample collection; Stool diaper data and sample collection

Outcome Measures

Primary Outcome Measures

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 [7 days]

   To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis

Secondary Outcome Measures

1. To assess the microbiome composition in the stool sample of the subject [7 days]

   To assess the microbiome composition in the stool sample of the subject

2. To assess the dietary pattern based on Food Frequency Questionnaire (FFQ) [7 days]

   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

3. To explore the association between microbiome composition and known factors that influence the microbiome in early life [7 days]

   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

Other Outcome Measures

1. The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents [7 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Months to 18 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Malaya Medical Center	Kuala Lumpur		Malaysia	59100
2	National University Hospital, Singapore	Singapore		Singapore	119074
3	Mount Elizabeth Medical Centre	Singapore		Singapore	228510
4	KK Women's and Children's Hospital	Singapore		Singapore	229899
5	Thammasat University Hospital	Pathumthani		Thailand	12120

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
• ClinicalTrials.gov Identifier: NCT05847543
• Other Study ID Numbers: EBB19GC16961-A
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Danone Asia Pacific Holdings Pte, Ltd.: Microbiome; Artificial Intelligence; Stool

Study Results

No Results Posted as of May 6, 2023