- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04991818
MSC - OneBiome UX Pilot Study (OneBiome)
January 26, 2023 updated by: Danone Asia Pacific Holdings Pte, Ltd.
Evaluating the User Experience of the OneBiome Consumers Value Journey Service Offered to the 1000 Days and Young Children Consumers Market
Evaluating the user (pregnant women and parents of young children) experience of the OneBiome consumers value journey service offered to the 1000 days and young children consumers market
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The OneBiome service aims to empower consumers with microbiome science in a friendly/consumer centric manner.
The investigators wants to show that microbiome data can be used as an estimate of consumer's health and can be translated into actionable insights.
The investigators aim to pilot a consumers' insight study to measure the perception/sentiments of this service in the Singapore market by recruiting study subjects from local public/private hospitals.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Singapore, Singapore, 228510
- Mount Elizabeth Medical Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pregnant women who are in the third trimester, or children from birth to 5 years of age
- Pregnant women or parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
- Pregnant women or parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
- Pregnant women and parents of children should stay in Singapore and remain contactable should they decide to do two microbiome assessments within 8 weeks
Exclusion Criteria:
- Children born prematurely
- Incapability of the pregnant women or parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
- Any other family member is enrolled in the study
- Incapability of the pregnant women or parents of children to comply with study protocol or Investigator's uncertainty about the willingness or ability of the pregnant women or parents of children to comply with the protocol requirements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregnant women or children 0-5 years of age
Pregnant women in third trimester or children 0-5 years of age
|
participants will be asked to complete the user experience of the OneBiome service
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall user experience of the OneBiome microbiome profiling service
Time Frame: Approximately 8 weeks
|
Pregnant women and parents of young children reported overall user experience of the OneBiome microbiome profiling service, i.e. average rating of the four following UX surveys1) overall experience of kit discovery (from unboxing to shipment); 2) ease of use of the stool collection kit; 3) overall user experience of the OneBiome web platform; 4) overall user experience of reading and understanding the microbiome analysis report.
|
Approximately 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
User experience of different "steps/ phases" of the OneBiome consumers value journey service
Time Frame: Approximately 8 weeks
|
Pregnant women and parents of young children reported user experience of different "steps/ phases" of the OneBiome consumers value journey service, including 'kit discovery, 'kit usage', 'web platform', 'evaluation of report', 'evaluation of service' and ''evaluation of consumer's motivation and consumption behaviour habits'
|
Approximately 8 weeks
|
Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
Time Frame: Approximately 8 weeks
|
HCP reported overall user experience of the OneBiome microbiome profiling service
|
Approximately 8 weeks
|
HCP reported usefulness of microbiome data
Time Frame: Approximately 8 weeks
|
HCP reported usefulness of microbiome data for their general practice based on user experience interaction between HCP and pregnant women and parents of young children
|
Approximately 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome composition of the participants
Time Frame: Approximately 8 weeks
|
Microbiome composition in the stool sample of the subject which will be included in the microbiome analysis report to be shared with subject/ parent's subject.
|
Approximately 8 weeks
|
Association between microbiome composition and known factors that influence the microbiome
Time Frame: Approximately 8 weeks
|
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.
|
Approximately 8 weeks
|
Food frequency questionnaire translation into food groups
Time Frame: Approximately 8 weeks
|
FFQ data at the beginning and at the end of the study based on translation of FFQ into food groups according to the healthy plate guideline from the Health Promotion Board.
|
Approximately 8 weeks
|
Association between gut health parameters, stool images, microbiome composition and dietary patterns
Time Frame: Approximately 8 weeks
|
Association between gut health parameters (symptoms, stool consistency, frequency and color, gastrointestinal infection, antibiotic intake) and stool images from participants, and microbiome composition and dietary patterns
|
Approximately 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Bee Wah Lee, MD, The Child and Allergy Clinic
- Principal Investigator: Wen Chin Chiang, MD, Chiang Children's Allergy and Asthma Clinic
- Principal Investigator: Anne Goh, MD, KK Women's and Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
March 19, 2022
Study Completion (Actual)
April 29, 2022
Study Registration Dates
First Submitted
August 1, 2021
First Submitted That Met QC Criteria
August 1, 2021
First Posted (Actual)
August 5, 2021
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBB20R&33310
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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