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CompletedNCT06578351TRAMUpdated Feb 4, 2026

TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

An observational study in Atopic Dermatitis and Pediatric ALL, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Completed at 1 site in Singapore. Open to participants aged 0 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Danone Asia Pacific Holdings Pte, Ltd. (part of Danone) · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
0 Months to 12 Months
Sex
All
01

Study 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 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
02

Conditions studied

  • Atopic Dermatitis
  • Pediatric ALL

Keywords

  • microbiome
  • atopic dermatitis
  • pediatric
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 60 is below the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Infants with early onset eczema (n=30, \<12 months of age) and healthy infants (n=30, \<6 months of age).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Infants diagnosed with early onset eczema (\<12 months of age) and healthy infants (\<6 months of age, before weaning).
  2. Parents of children should have access to the internet and a smartphone or tablet to access the OneBiome mobile friendly website.
  3. Parents of children should be able to comprehend the content in the OneBiome mobile friendly website and complete the questionnaires in English.
  4. Parents of children should stay in Singapore and remain contactable.

Exclusion criteria

Exclusion Criteria:

  1. Children born prematurely.
  2. Children with a chronic illness.
  3. Children with congenital malformations, surgeries in the neonatal period or genetic syndromes.
  4. Incapability of the parents of children to access OneBiome mobile friendly website and complete the questionnaires in English.
  5. Any other family member is enrolled in the study.
  6. 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy Infants

    Healthy. no atopic dermatitis

  • Infants with early onset of eczema

    diagnosed with early onset eczema

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to age 18 months

  2. 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.

    Time frame: 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.

    Time frame: Up to age 18 months

Other outcomes

  1. Association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life

    To investigate association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life including mode of delivery, antibiotic prophylaxis, infant feeding patterns and diet.

    Time frame: Up to age 18 months

  2. Association between microbiome composition, dietary/eating patterns, and gut health parameters

    To determine any association between microbiome composition, dietary/eating patterns, and gut health parameters (stool consistency, frequency, colour, constipation, gastrointestinal infection, antibiotic intake) including stool images.

    Time frame: Up to age 18 months

07

Study locations

1 site
  • Mount Elizabeth Hospital
    Singapore, 228510, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06578351
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Apr 8, 2024
Primary completion
Jan 26, 2026
Completion
Jan 26, 2026
Last update
Feb 4, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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