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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010839
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of pediatrics, Graduate School of Medicine, Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010485

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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