TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM) (TRAM)

February 2, 2026 updated by: Danone Asia Pacific Holdings Pte, Ltd.
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

60

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, Singapore, 228510
        • Mount Elizabeth Hospital

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

  • Child

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).

Description

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:

  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.

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

Cohorts and Interventions

Group / Cohort
Healthy Infants
Healthy. no atopic dermatitis
Infants with early onset of eczema
diagnosed with early onset eczema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Up to age 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCP reported applicability of OneBiome concept by parents via a survey form
Time Frame: Up to age 18 months
HCP reported applicability of microbiome/eating pattern profiles of their patients for their general practice, and to assess parents' overall feedback on OneBiome concept.
Up to age 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life
Time Frame: Up to age 18 months
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.
Up to age 18 months
Association between microbiome composition, dietary/eating patterns, and gut health parameters
Time Frame: Up to age 18 months
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.
Up to age 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Investigators

  • Principal Investigator: Bee Wah Lee, MBBS, The Child and Allergy Clinic - Mount Elizabeth Hospital
  • Principal Investigator: Wen Chin Chiang, MBBS, Chiang's Children Allergy and Asthma Clinic - Mount Elizabeth 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)

April 8, 2024

Primary Completion (Actual)

January 26, 2026

Study Completion (Actual)

January 26, 2026

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBB20R&33310_A

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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