TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

NCT06578351 | Completed

• 1 other identifier: SBB20R&33310_A
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Pediatric ALL

Keywords

microbiome; atopic dermatitis; pediatric

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to age 18 months

Secondary Outcomes (1)

• HCP reported applicability of OneBiome concept by parents via a survey form

  Up to age 18 months

Other Outcomes (2)

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

  Up to age 18 months

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

  Up to age 18 months

Study Arms (2)

Healthy Infants

Healthy. no atopic dermatitis

Infants with early onset of eczema

diagnosed with early onset eczema

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead

Study Sites (1)

Mount Elizabeth Hospital

Singapore, 228510, Singapore

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample

MeSH Terms

Conditions

Dermatitis, Atopic; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 29, 2024
• Study Start: April 8, 2024
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

SG (1)