Clinical trial NCT06578351: TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
Official title: TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Pediatric ALL
Keywords: microbiome
atopic dermatitis
pediatric
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: user experience using a survey form to evaluate user's understanding of OneBiome report
timeFrame: Up to age 18 months
measure: user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern
timeFrame: Up to age 18 months
Secondary outcomes:
measure: HCP reported applicability of OneBiome concept by parents via a survey form
timeFrame: Up to age 18 months
Other outcomes:
measure: Association between microbiome composition, eczema conditions and known factors that influence the microbiome in early life
timeFrame: Up to age 18 months
measure: Association between microbiome composition, dietary/eating patterns, and gut health parameters
timeFrame: Up to age 18 months
Locations:
city: Singapore
country: Singapore
facility: Mount Elizabeth Hospital
Study officials:
affiliation: The Child and Allergy Clinic - Mount Elizabeth Hospital
name: Bee Wah Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang's Children Allergy and Asthma Clinic - Mount Elizabeth Hospital
name: Wen Chin Chiang, MBBS
role: PRINCIPAL_INVESTIGATOR
References: