Condition category
Respiratory
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
13/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.iow.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes