Atopic DermatitisTRAMNCT06578351
TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
An observational study of Atopic Dermatitis and Pediatric ALL, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial summary
TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform. Read more about this study
- Who is it for?
- Ages 0 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Pediatric ALL
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Apr 2024to 26 Jan 2026
- Phase
- Observational
- 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 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants with early onset eczema (n=30, <12 months of age) and healthy infants (n=30, <6 months of age).
Who may be able to join
- Infants diagnosed with early onset eczema (<12 months of age) and healthy infants (<6 months of age, before weaning).
- Parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
- Parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
- Parents of children should stay in Singapore and remain contactable.
Who cannot join
- Children born prematurely.
- Children with a chronic illness.
- Children with congenital malformations, surgeries in the neonatal period or genetic syndromes.
- Incapability of the 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform.
Read the detailed description
Parents of healthy infants as well as parents of infants with early onset eczema:
- user experience of reading and understanding the microbiome and eating pattern analysis reports
- user experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime
- Conditions
- Atopic Dermatitis, Pediatric ALL
- Keywords
- microbiome, atopic dermatitis, pediatric
- Medical subject headings
- Dermatitis, Atopic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Infants | Healthy. no atopic dermatitis | |
| Infants with early onset of eczema | diagnosed with early onset eczema |
What is being measured
The primary outcome is the main question the study is designed to answer.
user experience using a survey form to evaluate user's understanding of OneBiome report
user experience of reading and understanding the microbiome and eating pattern analysis reports.
Measured: Up to age 18 months
user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern
User experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime.
Measured: Up to age 18 months
Secondary outcomes (1)
HCP reported applicability of OneBiome concept by parents via a survey form
HCP reported applicability of microbiome/eating pattern profiles of their patients for their general practice, and to assess parents' overall feedback on OneBiome concept.
Measured: Up to age 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start8 Apr 2024
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bee Wah Lee, MBBS, Principal investigator, The Child and Allergy Clinic - Mount Elizabeth HospitalWen Chin Chiang, MBBS, Principal investigator, Chiang's Children Allergy and Asthma Clinic - Mount Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578351
- Sponsor's protocol ID
- SBB20R&33310_A
- Acronym
- TRAM
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2024
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
- ClinicalTrials.gov ID
- NCT06578351
- Acronym / sponsor ID
- TRAM / SBB20R&33310_A
- Conditions
- Atopic Dermatitis, Pediatric ALL
- Keywords
- microbiome, atopic dermatitis, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 29 Aug 2024 (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.
TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research platform.
Detailed description
Parents of healthy infants as well as parents of infants with early onset eczema:
- user experience of reading and understanding the microbiome and eating pattern analysis reports
- user experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Infants | – | –Healthy. no atopic dermatitis |
| Infants with early onset of eczema | – | –diagnosed with early onset eczema |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants with early onset eczema (n=30, <12 months of age) and healthy infants (n=30, <6 months of age).
Key inclusion criteria (4 listed)
- Infants diagnosed with early onset eczema (<12 months of age) and healthy infants (<6 months of age, before weaning).
- Parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
- Parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
- Parents of children should stay in Singapore and remain contactable.
Key exclusion criteria (6 listed)
- Children born prematurely.
- Children with a chronic illness.
- Children with congenital malformations, surgeries in the neonatal period or genetic syndromes.
- Incapability of the parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
- Any other family member is enrolled in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
user experience using a survey form to evaluate user's understanding of OneBiome report
Time frame: Up to age 18 months
user experience of reading and understanding the microbiome and eating pattern analysis reports.
user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern
Time frame: Up to age 18 months
User experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime.
1 secondary outcome
HCP reported applicability of OneBiome concept by parents via a survey form
Time frame: Up to age 18 months
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 4 Feb 2026.
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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, MBBS principal investigator
The Child and Allergy Clinic - Mount Elizabeth Hospital
Wen Chin Chiang, MBBS principal investigator
Chiang's Children Allergy and Asthma Clinic - Mount Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Pediatric ALL, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site 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 6 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
user experience using a survey form to evaluate user's understanding of OneBiome report (time frame: Up to age 18 months). The study lists 2 primary outcomes in all. 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 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.