Oral treatment of allergy with a non-pathogenic microorganism: A randomised clinical trial - TSO-01

Statens Serum Institut0 sitesNovember 20, 2007

Overview

No summary available.

Registry

who.int

Start Date

November 20, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Male or female, aged \>18 and \<65 years
•2\.Symptoms of birch and/or grass pollen allergy the last 2 pollen seasons, or more.
•3\.Forced Expiratory Volume 1 \>70% of expected.
•4\.Scoring all symptoms of allergic rhinitis \>50 mm on a 100 mm VAS (0\=not bothersome, 10\=worst)
•5\.Specific IgE class \>2 to birch and/or grass (\>0\.7 kUallergen/l)
•6\.A positive skin prick test (\>3mm) to birch and/or grass
•7\.Women must not be pregnant, and women in fertile age must have a negative pregnancy test, not be breastfeeding, and use birth control during the trial unless sterile or post meno\-pausal
•8\.Prepared to grant authorized persons access to medical records
•9\.The volunteer is likely to comply with instructions
•Are the trial subjects under 18? no

•1\.Significant asthma
•2\.Use of systemic steroids during the last 2 months
•3\.Immune therapy for birch or grass pollen allergy the last 2 years, or more.
•4\.Planning a travel abroad during the trial period (excluding areas with a similar grass/birch pollen counts when compared with the Copenhagen area)
•5\.Past or current severe diseases (a history of active hepatitis B or C, cytomegalovirus, herpes simplex, HIV, other kinds of immune deficiency, and cancer)
•6\.Anti\-helminth treatment within the last 2 weeks (e.g mebendazol)
•7\.Known or possible hypersensitivity to Trichuris species or compounds made of Trichuris species
•8\.A past or recent drug abuse
•9\.Participation in other clinical trials
•10\.Employed with the Investigator (Pulmonology\- and Allergy Clinic Copenhagen (center of trial)), or the relevant department at the sponsor institution (Department of Epidemiology Research at Statens Serum Institut).