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

• Conditions: Allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis

• Registration Number: EUCTR2007-006099-12-DK
• Lead Sponsor: Statens Serum Institut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of transient Trichuris suis infestation of the gut on self-reported symptoms of allergic rhinitis and number of well-days among adults with allergic rhinitis.;Secondary Objective: To assess the efficacy and safety of transient Trichuris suis infestation of the gut on allergic rhinitis and asthma assessed through self-reported disease activity, clinical skin and airway activity, and immunological activity among adults with allergic rhinitis.;Primary end point(s): Daily score for symptoms of allergic rhinitis, and number of well days during the pollen season.