Condition category
Genetic Diseases
Date applied
23/07/2014
Date assigned
08/04/2015
Last edited
09/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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?
From July 2014 to March 2017.

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Georgina Williams

ORCID ID

Contact details

NIHR Bristol Nutrition BRU
Level 3
University Hospitals Bristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16735

Study information

Scientific title

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

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16735

Ethics approval

NRES Committee South West – Central Bristol, 23/04/2014, ref: 14/fw0030

Study design

Non-randomised; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/07/2014

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

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

United Kingdom

Trial participating centre

The National Institute for Health Research Biomedical Research Unit in Nutrition, Diet and Lifestyle
University Hospitals Bristol NHS Foundation Trust University of Bristol
Bristol
BS2 8AE
United Kingdom

Trial participating centre

Over 200 sites
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research Enterprise and Development
Senate House
Tyndall Avenue
Clifton
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Biomedical Research Unit (BRU) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes