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TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

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Danone

Status

Completed

Conditions

Atopic Dermatitis
Pediatric ALL

Study type

Observational

Funder types

Industry

Identifiers

NCT06578351
SBB20R&33310_A

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

Under 12 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Healthy Infants
Description:
Healthy. no atopic dermatitis
Infants with early onset of eczema
Description:
diagnosed with early onset eczema

Trial contacts and locations

1

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Central trial contact

Claudia Lee, BSc; Christophe Lay, PhD

Data sourced from clinicaltrials.gov

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