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

Statens Serum Institut0 个研究点开始时间: 2007年11月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•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).

发起方