Contact information
Type
Scientific
Primary contact
Dr Graham Roberts
ORCID ID
Contact details
Surgery Unit
F Level
Centre Block
Mailpoint 816
Tremona Road
Southampton
SO16 6YD
United Kingdom
g.c.roberts@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4476
Study information
Scientific title
Primary prevention of asthma and atopy during childhood and adolescence by allergen avoidance in infancy: a randomised controlled study
Acronym
Study hypothesis
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
Portsmouth and SE Hampshire approved on the 15th February 2008 (ref: 07/H0504/188)
Study design
Single centre randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/05/2008
Overall trial end date
30/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Participation in the 1990 Isle of Wight Prevention Cohort Study
2. Aged 18 years or older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 120; UK sample size: 120
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/05/2008
Recruitment end date
30/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Surgery Unit
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Isle of Wight Healthcare NHS Trust (UK)
Sponsor details
St. Marys Hospital
Parkhurst Road
Newport
PO30 5TG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22858926
Publication citations
-
Results
Scott M, Roberts G, Kurukulaaratchy RJ, Matthews S, Nove A, Arshad SH, Multifaceted allergen avoidance during infancy reduces asthma during childhood with the effect persisting until age 18 years., Thorax, 2012, 67, 12, 1046-1051, doi: 10.1136/thoraxjnl-2012-202150.