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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018475
Receipt No. R000021393
Scientific Title Analysis of IgE level change by normal diet in healthy subjects
Date of disclosure of the study information 2015/09/01
Last modified on 2016/08/04

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Basic information
Public title Analysis of IgE level change by normal diet in healthy subjects
Acronym Analysis of IgE level change by normal diet
Scientific Title Analysis of IgE level change by normal diet in healthy subjects
Scientific Title:Acronym Analysis of IgE level change by normal diet
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Amelioration of food allergy by normal food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood IgE level after one month
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1.An intervention period: Four weeks
2.The number of times of the intervention:
Three time a day(84 times of total)
3.Meal(Nutritive value per day:energy 1800kcal)
4.We gave 125ml of lactic acid bacterium drinks (L cold re-YIT9029: More than 1250 million)16 times.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria healthy volunteers
Key exclusion criteria the sick
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuro Tanaka
Organization Tokyo University of Agriculture
Division name Faculty of Applied Biosciences
Zip code
Address 1-1-1, Sakuragaoka, Setagaya, Tokyo
TEL 03-5477-2220
Email e3tanaka@nodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Etsuro Tanaka
Organization Tokyo University of Agriculture
Division name Faculty of Applied Biosciences
Zip code
Address 1-1-1, Sakuragaoka, Setagaya, Tokyo
TEL 03-5477-2220
Homepage URL
Email e3tanaka@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization Tokyo University of Agriculture
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 09 Month 01 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 Completed
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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
2015 Year 07 Month 29 Day
Last modified on
2016 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021393

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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