Primary prevention of asthma and atopy during childhood and adolescence by allergen avoidance
| ISRCTN | ISRCTN96472018 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96472018 |
| Protocol serial number | 4476 |
| Sponsor | Isle of Wight Healthcare NHS Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) |
- 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
Scientific
Surgery Unit
F Level, Centre Block
Mailpoint 816, Tremona Road
Southampton
SO16 6YD
United Kingdom
| g.c.roberts@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional prevention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Asthma, measured using questionnaires and assessment of other charateristics such as lung function. |
| Key secondary outcome measure(s) |
1. Atopy, measured using skin prick test |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Surgery Unit
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
