Probiotics in the prevention of atopy in infants and childre
- Conditions
- Atopy in infants and childrenSigns and SymptomsAtopy
- Registration Number
- ISRCTN26287422
- Lead Sponsor
- niversity of Wales, Swansea (UK)
- Brief Summary
Abstract results in http://dx.doi.org/10.1136/archdischild-2012-301885.5 results in: Allen SJ, Jordan S, Storey M, Thornton C, Gravenor M, et al.. () Probiotics and atopic eczema: A double-blind randomised controlled trial. Arch Dis Child 97 S1 A2 P05. 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20089774 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24947281 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29769554 5-year extension results (added 24/10/2019) 2013 Results article in https://pubmed.ncbi.nlm.nih.gov/23874465/ (added 28/06/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 454
600 women and their newborn infants recruited from the antenatal department of a maternity unit of a district general hospital, with informed written consent. Infants have a first degree relative with an atopic disorder.
1. Mother aged less than 16 years
2. Multiple pregnancy
3. Gestation at delivery less than 36 weeks
4. Parents unable or unwilling to give informed consent
5. Any adverse medical condition affecting the pregnancy or its likely outcome (e.g. known abnormality in foetus)
6. Member of sibship or household already recruited to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The presence of eczema during infancy (assessed by the SCORAD system)<br>2. The presence of asthma in children in the first five years<br>3. Changes in key immunological parameters associated with atopy
- Secondary Outcome Measures
Name Time Method 1. Compliance with/adherence to trial intervention<br>2. Adverse events