TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

NCT ID: NCT06578351

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-08

Study Completion Date

2026-12-31

Brief Summary

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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

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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

Conditions

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Atopic Dermatitis Pediatric ALL

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Infants

Healthy. no atopic dermatitis

No interventions assigned to this group

Infants with early onset of eczema

diagnosed with early onset eczema

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Asia Pacific Holdings Pte, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bee Wah Lee, MBBS

Role: PRINCIPAL_INVESTIGATOR

The Child and Allergy Clinic - Mount Elizabeth Hospital

Wen Chin Chiang, MBBS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Mount Elizabeth Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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SBB20R&33310_A

Identifier Type: -

Identifier Source: org_study_id

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