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Completed

NCT Number: NCT06578351

TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Elizabeth Hospital

Singapore, 228510

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Industry

Registry information

Acronym: TRAM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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