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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: 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 nappy' (i.e. from the same stool). In order to acquire a 'fresh' stool we will ask parents to check their baby's nappy regularly within one hour after a feed as babies tend to have a pronounced gastro‐colic reflex. – I don’t think this needs to be included as not part of the main study Phase 2: Parents will be asked to complete questionnaires at baseline detailing family history, birth history, weight, medical problems and early feeding. They will have further feeding questionnaires to complete at 7 months and 12 months, and medical questionnaires annually until the age of 5 years. Samples would be collected at baseline including faeces to look at gut microbiome, a brushing from the infant's cheek for genotyping, a blood sample to look at development of auto‐antibody production (specifically autoantibodies to insulin, GAD, IA‐2 and ZnT8R/W, which are all associated with type 1 diabetes, anti‐BSA antibody, antibodies to tissue transglutaminase (Tg), antibodies to thyroid peroxidase (TPO), antibodies to gastric H+/K+ ATPase 4A), and a urine specimen for urinary c peptide to detect development of diabetes. Further stool, urine and blood samples will be collected at 6 and 12 months and once a year thereafter until 5 years of age. CONDITION: Topic: Children; Subtopic: All Diagnoses; Disease: Down's syndrome, autoimmunity ; Genetic Diseases ; Down syndrome PRIMARY OUTCOME: 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 OUTCOME: 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. 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
Epistemonikos ID: 185c17e49fc398f13a6d616a202dfeb7f3526871
First added on: Aug 23, 2024