TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06578351

Acronym

TRAM

Enrollment

Registered

2024-08-29

Start date

2024-04-08

Completion date

2026-01-26

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Pediatric ALL

Keywords

microbiome, atopic dermatitis, pediatric

Brief 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.

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Months to 12 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
user experience using a survey form to evaluate user's understanding of OneBiome report	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	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.

Secondary

Measure	Time frame	Description
HCP reported applicability of OneBiome concept by parents via a survey form	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.

Countries

Singapore

Contacts

PRINCIPAL_INVESTIGATORBee Wah Lee, MBBS

The Child and Allergy Clinic - Mount Elizabeth Hospital

PRINCIPAL_INVESTIGATORWen Chin Chiang, MBBS

Chiang's Children Allergy and Asthma Clinic - Mount Elizabeth Hospital

Outcome results