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ISRCTN
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ISRCTN96472018
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ClinicalTrials.gov identifier
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Public title
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Primary prevention of asthma and atopy during childhood and adolescence by allergen avoidance
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Scientific title
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Primary prevention of asthma and atopy during childhood and adolescence by allergen avoidance in infancy: a randomised controlled study
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Acronym
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N/A
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Serial number at source
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4476
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Portsmouth and SE Hampshire approved on the 15th February 2008 (ref: 07/H0504/188)
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Study design
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Single centre randomised interventional prevention trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Respiratory, Inflammatory and Immune System; Subtopic: Inflammatory and Immune System (all Subtopics), Respiratory (all Subtopics); Disease: Multiple complications, Immunology and inflammation, Respiratory
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Participants - inclusion criteria
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1. Participation in the 1990 Isle of Wight Prevention Cohort Study
2. Aged 18 years or older, either sex
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/05/2008
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Anticipated end date
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30/04/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 120; UK sample size: 120
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Interventions
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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
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Primary outcome measure(s)
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Asthma, measured using questionnaires and assessment of other charateristics such as lung function.
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Secondary outcome measure(s)
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1. Atopy, measured using skin prick test
2. Eczema, measured using questionnaires and SCORAD
3. Food allergy
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Sources of funding
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National Institute for Health Research (NIHR) (UK)
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Trial website
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Publications
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Contact name
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Dr
Graham
Roberts
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Address
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Surgery Unit
F Level, Centre Block
Mailpoint 816, Tremona Road
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City/town
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Southampton
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Zip/Postcode
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SO16 6YD
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Country
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United Kingdom
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Email
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g.c.roberts@soton.ac.uk
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Sponsor
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Isle of Wight Healthcare NHS Trust (UK)
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Address
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St. Marys Hospital
Parkhurst Road
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City/town
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Newport
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Zip/Postcode
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PO30 5TG
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Country
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United Kingdom
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Sponsor website:
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http://www.iow.nhs.uk/
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Date applied
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24/06/2010
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Last edited
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15/11/2010
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Date ISRCTN assigned
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24/06/2010
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