TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)

Recruiting

• Conditions: Atopic Dermatitis; Pediatric ALL

• Registration Number: NCT06578351
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

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

Study Timeline

• Study Start: 2024-04-08
• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-04-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
user experience using a survey form to evaluate user's perspective on using OneBiome report to monitor microbiome and eating pattern	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.
user experience using a survey form to evaluate user's understanding of OneBiome report	Up to age 18 months	user experience of reading and understanding the microbiome and eating pattern analysis reports.

Secondary Outcome Measures

Name	Time	Method
HCP reported applicability of OneBiome concept by parents via a survey form	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.

Trial Locations

Locations (1)

Mount Elizabeth Hospital; 🇸🇬 Singapore, Singapore