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Pilotstudy: Probiotics in children with atopic dermatitis and food allergy: is there an in vivo or in vitro effect on the immunological response?


- candidate number1210
- NTR NumberNTR127
- ISRCTNISRCTN28834761
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsN/A 
- Public TitlePilotstudy: Probiotics in children with atopic dermatitis and food allergy: is there an in vivo or in vitro effect on the immunological response?
- Scientific TitleProbiotics in children with atopic dermatitis and food allergy: is there an in vivo or in vitro effect on the immunological response?
- ACRONYMN/A
- hypothesisTreatment with probiotics can alter the allergen-specific in vivo or in vitro immunological response in food-allergic children.
- Healt Condition(s) or Problem(s) studiedAtopic dermatitis , Food allergy
- Inclusion criteria1. 0-3 years of age;
2. Atopic dermatitis;
3. History strongly suggestive of food allergy or positive placebo-controlled food challenge;
4. IgE RAST >= 0.7 kU/l for at least 2 food allergens;
5. SPT >= 2+ for at least 2 food allergens.
- Exclusion criteria1. Other systemic diseases;
2. Immunocompromized;
3. Systemic treatment with immunomodulating drugs.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2003
- planned closingdate1-mrt-2005
- Target number of participants13
- InterventionsActive group: 3 months treatment with a daily dose of a mixture of probiotics.
Placebo group: 3 months treatment with a daily dose of placebo.
- Primary outcomeAllergen-specific T cell response, B cell response.
- Secondary outcomeSCORAD, IgE RAST, SPT.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. E. Hoffen, van
- CONTACT for SCIENTIFIC QUERIESDr. E. Hoffen, van
- Sponsor/Initiator Winclove BioIndustries BV
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsInt Arch Allergy Immunol. 2007;143(3):237-44. Epub 2007 Feb 9.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-aug-2005 - 2-jul-2008


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