UMIN-CTR Clinical Trial

Basic information
Public title	Oral treatment of allergy with a non-pathogenic microorganism: A randomised clinical trial
Acronym	Oral treatment of allergy with a non-pathogenic microorganism: A randomised clinical trial
Scientific Title	Oral treatment of allergy with a non-pathogenic microorganism: A randomised clinical trial
Scientific Title:Acronym	Oral treatment of allergy with a non-pathogenic microorganism: A randomised clinical trial
Region	Europe

Condition
Condition	Allergic rhinitis.
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Others
Basic objectives -Others	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.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Daily score for symptoms of allergic rhinitis, and number of well days during the pollen season.
Key secondary outcomes	Efficacy variables Self-reported disease activity related to allergic rhinitis a. Daily recording of use of medication for allergic rhinitis, calculated as a score during data management. b. Daily score for all symptoms of allergic rhinitis on a 100mm visual analog scale (VAS). c. Assessment at the end of the trial of all symptoms of allergic rhinitis during the trial when compared with symptoms during the previous pollen season. d. Weekly score for quality of life using a validated Rhinitis Quality of Life Score. Clinical skin and airway activity e. Skin test reactivity to inhalant allergens. f. Degree of airway inflammation measured by amount of exhaled nitrogen oxid into a Niox apparatus. Immunological activity g. Reactivity of specific IgE and level of specific IgG/IgG4 to inhalant allergens measured by ImmunoCAPT. Differential blood count and total histamine in serum. h. Cytokines (IL-4, IL-5, IL-13, IL-10, TGFbeta, IFNgamma) measured as in vitro production from peripheral blood mononuclear cells in response to stimulation with allergens and Trichuris suis antigen (Subsample of 30 participants. Efficacy and safety variables Self-reported disease activity related to asthma and adverse events i. Daily recording of use of medication for asthma, calculated as a score during data management. j. Daily score for symptoms of asthma (safety variable). k. Daily adverse events (safety variable) Clinical airway activity l. Daily lung function measured as forced expiratory volume 1 (FEV1, safety variable) and peak expiratory force (PEF) using a pocket flow-meter.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	trichuris suis ova
Interventions/Control_2	placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Male or non-fertile female, aged above 17 and below 66 years; Symptoms of grass pollen allergy the last 2 pollen seasons, or more; Forced Expiratory Volume 1 above 70 percent of expected; Scoring all symptoms of allergic rhinitis above 50 mm on a 100 mm VAS during previous pollen season; Specific IgE RAST class higher than 1 against grass; A positive skin prick test larger than 2mm against grass; Prepared to grant authorized persons access to medical records; The volunteer is likely to comply with instructions
Key exclusion criteria	Significant asthma; Use of systemic steroids during the last 2 months; Immune therapy for grass pollen allergy the last 2 years; Planning a travel abroad during the trial period excluding areas with a similar grass or birch pollen counts when compared with the Copenhagen area; Past or current severe diseases eg a history of Crohns disease, ulcerative colitis, multiple sclerosis, active hepatitis B or C, cytomegalovirus, herpes simplex, HIV, other kinds of immune deficiency, and cancer; Anti-helminth treatment within the last 2 weeks; Known or possible hypersensitivity to Trichuris species or compounds made of Trichuris species; A past or recent drug abuse; Participation in other clinical trials; Employed with the Investigator, or the representative department at the sponsor institution
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Dr. Mads Melbye/Dr. John Arnved
Organization	Statens Serum Institut Pulmonology and Allergy Clinic Copenhagen
Division name	Epidemiology Research
Zip code
Address	Artillerivej 5, DK-2300 Copenhagen Denmark
TEL	+81-04532688327
Email

Public contact
Name of contact person	1st name Middle name Last name Mads Melbye, Executive Vicepresident
Organization	Statens Serum Institut
Division name	Epidemiology Research
Zip code
Address	Artillerivej 5, DK-2300 Copenhagen, Denmark
TEL	+81-04532683163
Homepage URL	http://www.ssi.dk/sw15515.asp
Email	mme@ssi.dk

Sponsor
Institute	Sponsor's representative: Mads Melbye, Executive Vicepresident, Statens Serum Institut, Dept. Epidemiology Research, Artillerivej 5, DK-2300 Copenhagen, Denmark
Institute
Department

Funding Source
Organization	- Statens Serum Institut - Danish Agency for Science, Technology, and innovation under the Danish Ministry of Science, Technology and innovation. - The Maersk Foundation (AP Moeller)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Denmark

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	Eudract no 2007-006099-12
Org. issuing International ID_1	European Medicine Agency
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Journal of Allergy and Clinical Immunology. In press, September 2009. Title: Trichuris suis ova therapy for allergic rhinitis: A randomized double-blind placebo-controlled clinical trial. Authors: Bager P, et al.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date	2008 Year 03 Month 01 Day
Last follow-up date	2008 Year 12 Month 01 Day
Date of closure to data entry	2008 Year 12 Month 01 Day
Date trial data considered complete	2009 Year 01 Month 01 Day
Date analysis concluded	2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2008 Year 03 Month 08 Day
Last modified on	2009 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001298

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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