UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010839 |
|---|---|
| Receipt number | R000010485 |
| Scientific Title | The Exploratory Study of Efficacy on Rush Oral Immunotherapy for Food Allergy Patients Given Lactobacillus Paracasei KW Concurrently |
| Date of disclosure of the study information | 2013/05/31 |
| Last modified on | 2013/05/30 11:29:48 |
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Basic information
Public title
The Exploratory Study of Efficacy on Rush Oral Immunotherapy for Food Allergy Patients Given Lactobacillus Paracasei KW Concurrently
Acronym
The Exploratory Study of Efficacy on Rush Oral Immunotherapy for Food Allergy Patients Given Lactobacillus Paracasei KW Concurrently
Scientific Title
The Exploratory Study of Efficacy on Rush Oral Immunotherapy for Food Allergy Patients Given Lactobacillus Paracasei KW Concurrently
Scientific Title:Acronym
The Exploratory Study of Efficacy on Rush Oral Immunotherapy for Food Allergy Patients Given Lactobacillus Paracasei KW Concurrently
Region
| Japan |
Condition
Condition
milk allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to find a treatment for food allergy with KW bacilus having TH1 adjuvant action
Basic objectives2
Others
Basic objectives -Others
to understand the mechanism of oral tolerance in food allergy from analysis of data and samples of patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of the symptom provocation threshold change at the time of entry and 2 months from the start of maintenance phase
Key secondary outcomes
1:evaluation of the symptom provocation threshold change at the time of entry and 12 months from the start of maintenance phase
2:analysis of adverse events
3:analysis of venous blood,saliva and stool sample and evaluation of the change of skin prick test at entry,rush phase and maintenance phase
4:analysis of score change at the time of entry, 2 months and 12 months from the start of maintenance phase with QOL survey sheets
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Lactobacillus Paracasei KW
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) having cow's milk allergy
2) cow's milk allergy not getting cured
3) The threshold of allergy symptom provocation is less than 10ml cow's milk intake.
4) having no communication difficulty
5) having parent's consent
Key exclusion criteria
1) having soybean allergy
2) having dextrine allergy
3) the amount intake of cow's milk changing significantly during the past three months
4) having a heart,liver or kidney disease under treatment
5) having uncontrollable
asthma or atopic dermatitis
6) suspected having HIV, HBV ,HCV or other infectious agent
7) any inappropriate status judged by physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Shimojo |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of pediatrics
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of pediatrics
Zip code
Address
TEL
043-226-2144
Homepage URL
Sponsor or person
Institute
Department of pediatrics, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 30 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010485
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
