Clinical trial NCT05847543: Building an AI to Infer/Predict an Estimated Stool Microbiome Profile
Official title: A Study to Develop, Evaluate, and Validate a Tool to Infer/Predict an Estimated Microbiome Profile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Microbiome
Artificial Intelligence
Stool
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KK Women's and Children's Hospital
name: National University Hospital, Singapore
name: University of Malaya
name: Thammasat University Hospital
name: Mount Elizabeth Medical Centre
First posted: 2023-05-06
Enrollment: 440
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term children aged 0 to 18 months old

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To collect stool data and stool samples for full microbiome analysis. To collect stool images, stool data and stool samples for full microbiome analysis
timeFrame: 7 days
Secondary outcomes:
measure: To assess the microbiome composition in the stool sample of the subject
timeFrame: 7 days
measure: To assess the dietary pattern based on Food Frequency Questionnaire (FFQ)
timeFrame: 7 days
measure: To explore the association between microbiome composition and known factors that influence the microbiome in early life
timeFrame: 7 days
Other outcomes:
measure: The accuracy level of the stool AI in predicting the stool consistency using BITSS versus the scores provided by parents
timeFrame: 7 days
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
city: Singapore
country: Singapore
facility: Mount Elizabeth Medical Centre
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital
Study officials:
References: