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Feeding and Autoimmunity in Down's syndrome Evaluation Study (FADES)

Feeding and Autoimmunity in Down's syndrome Evaluation Study (FADES): an observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12415856
Enrollment
200
Registered
2015-04-08
Start date
2014-07-01
Completion date
Unknown
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Children

Interventions

Phase 1: Samples will be collected by parents on the ward from their baby's nappy. The samples need to be 'fresh' (passed within an hour) and they will need to take three samples from the same 'dirty

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Babies recruited antenatally or in the first 8 months of life born with Down's syndrome (three copies of chromosome 21) as confirmed by karyotype after birth

Exclusion criteria

Exclusion criteria: 1. Babies with Down's syndrome who have a child protection plan or who are no longer with their birth mother 2. Babies with Down's syndrome over 8 months of age 3. Babies with Down's syndrome in whom the parents do not speak English

Design outcomes

Primary

MeasureTime frame
As a feasibility study the primary outcome is to have established a cohort of children with Down’s syndrome in which we have been able to record early feeding practice and obtain samples from which we can study the development and natural history of autoimmunity in relation to feeding and the gut microbiome.

Secondary

MeasureTime frame
Comparing babies with Down's syndrome who have breastfed with those that have not, we will be studying: 1. Whether they have significant differences in autoantibody status 2. Whether they have differences in the diversity of their gut microbiomes We would also be investigating the correlation between levels of anti-BSA antibodies and correlate with autoantibody positivity in all participants who had been exposed to cow's milk protein.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026