UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001070 |
|---|---|
| Receipt number | R000001298 |
| Scientific Title | Oral treatment of allergy with a non-pathogenic microorganism: A randomised clinical trial |
| Date of disclosure of the study information | 2008/12/31 |
| Last modified on | 2009/09/08 16:59:23 |
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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
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
mme@ssi.dk
Sponsor or person
Institute
Sponsor's representative:
Mads Melbye, Executive Vicepresident,
Statens Serum Institut,
Dept. Epidemiology Research,
Artillerivej 5,
DK-2300 Copenhagen,
Denmark
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001298
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| Registered date | File name |
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| Registered date | File name |
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