Primary prevention of asthma and atopy during childhood and adolescence by allergen avoidance

ISRCTN	ISRCTN96472018
DOI	https://doi.org/10.1186/ISRCTN96472018
Secondary identifying numbers	4476

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 13/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Graham Roberts
Scientific

Surgery Unit
F Level, Centre Block
Mailpoint 816, Tremona Road
Southampton
SO16 6YD
United Kingdom

Email	g.c.roberts@soton.ac.uk

Study information

Study design	Single centre randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Primary prevention of asthma and atopy during childhood and adolescence by allergen avoidance in infancy: a randomised controlled study
Study objectives	Asthma and allergic diseases affect millions of people in the UK. Asthma is the most common chronic disease in children. Their quality of life is severely affected, some live in a constant fear of another attack. We can significantly improve the health of future generations, if we can prevent the development of these diseases. It is therefore important to devise effective preventive strategies. It is well known that both genetic and environmental factors contribute to the development of asthma and allergy. Thus, children with a family history of allergy are at higher risk. Exposure to allergens in early childhood may be one of the most important environmental factors. In 1990 we embarked on a study to test the effectiveness of strict dietary avoidance of food allergens combined with reduced exposure to house dust-mite allergen. Infants, at higher risk due to family predisposition, were recruited before birth and assigned randomly to prophylactic (n = 58) or control (n = 62) groups. Prophylactic group infants were either breast-fed with mothers on a low allergen diet or given hypoallergenic milk formula and exposure to house dust-mite was reduced. All 120 children have been seen at ages 1, 2, 4 and 8 years. The prophylactic children were less sensitised to allergens and developed less asthma and eczema up to the age of 8 years and there was no loss of preventive effect up to this age. Since this study commenced in 1990, no other intervention has succeeded in achieving such an impact on asthma and allergy. These children are now 18 years. We wish to see them again and make a comprehensive assessment of their asthma and allergy status to ascertain if the effect of reduced allergen exposure in infancy continues into adolescence and early adulthood.
Ethics approval(s)	Portsmouth and SE Hampshire approved on the 15th February 2008 (ref: 07/H0504/188)
Health condition(s) or problem(s) studied	Topic: Respiratory, Inflammatory and Immune System; Subtopic: Inflammatory and Immune System (all Subtopics), Respiratory (all Subtopics); Disease: Multiple complications, Immunology and inflammation, Respiratory
Intervention	Initially, participants in 1990 were infants at higher risk due to family predisposition. These infants were recruited before birth and assigned randomly to prophylactic (n = 58) or control (n = 62) groups. Prophylactic group infants were either breast-fed with mothers on a low allergen diet or given hypoallergenic milk formula and exposure to house dust-mite was reduced. Follow-up was at ages 1, 2, 4 and 8 years. In this follow-up study, a comprehensive assessment of the initial participants' (now aged 18 years) asthma and allergy status is performed to ascertain if the effect of reduced allergen exposure in infancy continues into adolescence and early adulthood. Follow up length: 36 months Study entry: registration with blood and saliva sample collection
Intervention type	Other
Primary outcome measure	Asthma, measured using questionnaires and assessment of other charateristics such as lung function.
Secondary outcome measures	1. Atopy, measured using skin prick test 2. Eczema, measured using questionnaires and SCORAD 3. Food allergy
Overall study start date	01/05/2008
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 120; UK sample size: 120
Key inclusion criteria	1. Participation in the 1990 Isle of Wight Prevention Cohort Study 2. Aged 18 years or older, either sex
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/05/2008
Date of final enrolment	30/04/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Surgery Unit

Southampton
SO16 6YD
United Kingdom

Sponsor information

Isle of Wight Healthcare NHS Trust (UK)
Hospital/treatment centre

St. Marys Hospital
Parkhurst Road
Newport
PO30 5TG
England
United Kingdom

Website	http://www.iow.nhs.uk/
"ROR"	https://ror.org/013aa1717

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No