Microbial ColonizationOneBiomeNCT04991818
MSC - OneBiome UX Pilot Study
A study testing OneBiome microbiome profiling service in people with Microbial Colonization, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Singapore.
Trial 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 Read more about this study
- Who is it for?
- Ages 0 months and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- OneBiome microbiome profiling service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Sep 2021to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Mount Elizabeth Medical Centre
Singapore, 228510
KK Women's and Children's Hospital
Singapore, 229899
About this study
Official title: 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
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- OneBiome microbiome profiling service
- Keywords
- OneBiome, Consumer insights, User experience
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneBiome microbiome profiling serviceOther
participants will be asked to complete the user experience of the OneBiome service
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women or children 0-5 years of age | Experimental | Pregnant women in third trimester or children 0-5 years of age Receives: Other: OneBiome microbiome profiling service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall user experience of the OneBiome microbiome profiling service
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.
Measured: Approximately 8 weeks
Secondary outcomes (3)
User experience of different "steps/ phases" of the OneBiome consumers value journey service
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'
Measured: Approximately 8 weeks
Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
HCP reported overall user experience of the OneBiome microbiome profiling service
Measured: Approximately 8 weeks
HCP reported usefulness of microbiome data
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
Measured: Approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Sep 2021
- Primary completion19 Mar 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiang Children's Allergy and Asthma Clinic, The Child and Allergic Clinic, KK Women's and Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Bee Wah Lee, MD, Principal investigator, The Child and Allergy ClinicWen Chin Chiang, MD, Principal investigator, Chiang Children's Allergy and Asthma ClinicAnne Goh, MD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991818
- Sponsor's protocol ID
- SBB20R&33310
- Acronym
- OneBiome
- Status last verified
- Jan 2023
- First submitted
- 1 Aug 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the User Experience of the OneBiome Consumers Value Journey Service Offered to the 1000 Days and Young Children Consumers Market
- ClinicalTrials.gov ID
- NCT04991818
- Acronym / sponsor ID
- OneBiome / SBB20R&33310
- Conditions
- Microbial Colonization
- Keywords
- OneBiome, Consumer insights, User experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chiang Children's Allergy and Asthma Clinic, The Child and Allergic Clinic, KK Women's and Children's Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 19 Mar 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women or children 0-5 years of age | Experimental | Other: OneBiome microbiome profiling servicePregnant women in third trimester or children 0-5 years of age |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OneBiome microbiome profiling serviceparticipants will be asked to complete the user experience of the OneBiome service | Other | Pregnant women or children 0-5 years of age |
Primary outcome
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.
3 secondary outcomes
User experience of different "steps/ phases" of the OneBiome consumers value journey service
Time frame: Approximately 8 weeks
Healthcare professional (HCP) reported overall experience of the OneBiome consumers value journey service
Time frame: Approximately 8 weeks
HCP reported usefulness of microbiome data
Time frame: Approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
Related trials for Microbial Colonization
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 2/3
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
Chronic Hepatitis D
Enrolling by invitationObservational study
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
Inflammation
RecruitingPhase 2
Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy
Invasive Mould Infection
Not yet recruiting
Fermented Mare's Milk Supplementation During Acute Viral Respiratory Infection
Acute Respiratory Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bee Wah Lee, MD principal investigator
The Child and Allergy Clinic
Wen Chin Chiang, MD principal investigator
Chiang Children's Allergy and Asthma Clinic
Anne Goh, MD principal investigator
KK Women's and Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneBiome microbiome profiling service in people with Microbial Colonization, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall user experience of the OneBiome microbiome profiling service (time frame: Approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.