The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MSC - OneBiome UX Pilot Study (OneBiome)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04991818
Recruitment Status : Completed
First Posted : August 5, 2021
Last Update Posted : January 27, 2023
Sponsor:
Collaborators:
Chiang Children's Allergy and Asthma Clinic
The Child and Allergic Clinic
KK Women's and Children's Hospital
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Microbial Colonization Other: OneBiome microbiome profiling service Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating the User Experience of the OneBiome Consumers Value Journey Service Offered to the 1000 Days and Young Children Consumers Market
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : March 19, 2022
Actual Study Completion Date : April 29, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
 Other: OneBiome microbiome profiling service
participants will be asked to complete the user experience of the OneBiome service


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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'

  2. 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

  3. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   0 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pregnant women who are in the third trimester, or children from birth to 5 years of age
  2. Pregnant women or parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
  3. 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.
  4. 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:

  1. Children born prematurely
  2. Incapability of the pregnant women or parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
  3. Any other family member is enrolled in the study
  4. 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04991818


Locations
Layout table for location information
Singapore
Mount Elizabeth Medical Centre
Singapore, Singapore, 228510
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
Chiang Children's Allergy and Asthma Clinic
The Child and Allergic Clinic
KK Women's and Children's Hospital
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT04991818    
Other Study ID Numbers: SBB20R&33310
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023

Layout table for additional information
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.:
OneBiome
Consumer insights
User experience
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infections
Disease Attributes
Pathologic Processes