Feeding and Autoimmunity in Down's syndrome Evaluation Study (FADES)
| ISRCTN | ISRCTN12415856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12415856 |
| Secondary identifying numbers | 16735 |
- Submission date
- 23/07/2014
- Registration date
- 08/04/2015
- Last edited
- 17/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Genetic Diseases
Plain English Summary
Background and study aims
Children with Down's Syndrome (DS) have an increased risk of autoimmune conditions where the body's immune system attacks its own cells, such as thyroid problems, diabetes and coeliac disease. There is some evidence that prolonged breastfeeding protects against diabetes and coeliac disease. We think that in infants with DS early feeding practices may be related to the development of autoimmunity. Children with DS may have difficulties with breastfeeding, leading to rapid introduction of formula feeds. We aim to study the association between early infant feeding, infections and the development of autoimmunity.
Who can participate?
Babies less than 8 months old with DS.
What does the study involve?
Parents will be asked to complete questionnaires at the start of the study detailing family history, birth history, weight, medical problems and early feeding. They will have further feeding questionnaires at 7 and 12 months, and medical questionnaires annually until the age of 5 years. Samples will be collected at the start of the study including faeces, a brushing from the infant's cheek for genotyping (looking at their DNA), a blood sample to look at autoantibody production (antibodies which act against their own cells), and a urine specimen to detect development of diabetes. Further stool, urine and blood samples are collected at 6 months, 12 months and yearly thereafter until 5 years of age.
What are the possible benefits and risks of participating?
There are not any risks to taking part in the study. The heel/finger prick tests may cause some minor discomfort but there will only be seven of these over a five-year period. The participants will have additional questionnaires and samples to collect which families with a child with DS do not normally have to do. Apart from the initial blood test these samples can all be done at home if the parents feel able to do this or can be taken at the child's routine appointments and will not require any additional hospital attendances. We wish to try and find out what difficulties babies with DS have with feeding and infections and how this may contribute to the development of autoimmunity. Whilst our findings may not directly help the participants they may benefit children born with DS in the future and we are therefore relying on the research participants goodwill. From this study we hope to go on and do a further study to develop an intervention to help with feeding in babies born with DS. We also hope the study will increase knowledge in this area for the parents of children with DS as well as those that care for them.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
July 2014 to January 2022
Who is funding the study?
NIHR Biomedical Research Unit in nutrition, diet and lifestyle at University Hospitals Bristol NHS Foundation Trust and University of Bristol (UK)
Who is the main contact?
Dr Georgina Williams
Contact information
Scientific
NIHR Bristol Nutrition BRU
Level 3, University Hospitals Bristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Study information
| Study design | Non-randomised; Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Feeding and Autoimmunity in Down's syndrome Evaluation Study (FADES): an observational cohort study |
| Study acronym | FADES |
| Study hypothesis | This study will aim to establish the feasibility of developing a cohort from across the UK of children with Down’s Syndrome in whom we can study how feeding and early infections may be related to the increased risk children with Down’s Syndrome have of developing thyroid, coeliac disease and diabetes. |
| Ethics approval(s) | NRES Committee South West – Central Bristol, 23/04/2014, ref: 14/fw0030 |
| Condition | Topic: Children; Subtopic: All Diagnoses; Disease: Down's syndrome, autoimmunity |
| 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/07/2014 |
| Overall study end date | 01/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/07/2014 |
| Recruitment end date | 01/07/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
University of Bristol
Bristol
BS2 8AE
United Kingdom
United Kingdom
Sponsor information
University/education
Research Enterprise and Development
Senate House
Tyndall Avenue
Clifton
BS8 1TH
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2022 | 17/01/2023 | Yes | No |
Editorial Notes
17/01/2023: Publication reference added.
03/04/2018: The overall trial end date was changed from 31/03/2017 to 01/01/2022.
