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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024951
Receipt No. R000028699
Scientific Title Phase II-multicenter clinical trial of hypoallergenic wheat 1BS-18 Hokushin
Date of disclosure of the study information 2016/11/22
Last modified on 2019/05/27

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Basic information
Public title Phase II-multicenter clinical trial of hypoallergenic wheat 1BS-18 Hokushin
Acronym Clinical trial of 1BS-18
Scientific Title Phase II-multicenter clinical trial of hypoallergenic wheat 1BS-18 Hokushin
Scientific Title:Acronym Clinical trial of 1BS-18
Region
Japan

Condition
Condition Wheat allergy
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy of hyposensitization therapy by ingesting 1BS-18 Hokushin bread in patients with wheat allergy. The appropriate amount of 1BS-18 Hokushin bread is decided in individuals prior to the trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Decrease in reactivity to wheat allergens of basophil activating test.
Key secondary outcomes Rate of 0 score of subjective and objective symptoms after ingesting the 1BS-18 Hokushin bread. Evaluation is performed from 0 to 12 weeks.

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 Patients start the study within 4 weeks of enrollment.
1) Step 1: Evaluation of appropriate amount of 1BS-18 Hokushin bread.
1st week: 10g/day, every day.
2nd week: 20g/day, every day.
3rd week: 30g/day, every day.
4th week: 40g/day, every day.
5th week: 50g/day, every day.
6th week: 60g/day, every day.
2) Step 2: hyposensitization treatment. Ingestion of 1BS-18 Hokushin bread, maximum amount taken without allergic symptoms decided in Step 1, every day for 12 weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. More than 20 years old man and woman.
2. Patients who fulfil the diagnostic criteria of wheat-dependent exercise-induced anaphylaxis set by the study group of "Guideline for the treatment of life-threatening food allergy" supported by Health and Labour Sciences Research Grant, and those who have allergic reaction to wheat within one year, and/or those who avoid wheat ingestion because of the high titer of serum wheat-specific IgE prior to the 4 weeks of enrollment.
3. Patients who have positive specific IgE to omega-5 gliadin.
4. Patients who can visit doctor's office every 1-4 week(s).
5. Patients who can sign the treatment consent form.
Key exclusion criteria 1. Continuous taking antihistamines and/or non-steroidal anti-inflammatory drugs.
2. Patients who have allergy to milk product.
3. Patients who received immune-suppressing drug including high dose corticosteroid.
4. Patients with decompensated liver cirrhosis.
5. Patients with severe kidney disease; more than 2.0mg/dL of serum creatinine level within 4 weeks prior to the entry.
6. Pregnant women, breast-feeding women, and women suspected of being pregnant.
7. Patients ineligible for the clinical trial at a physician's discretion.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Eishin
Middle name
Last name Morita
Organization Shimane University
Division name Department of Dermatology
Zip code 6938501
Address Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2210
Email emorita@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Chinuki
Organization Shimane University
Division name Department of Dermatology
Zip code 6938501
Address Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2210
Homepage URL
Email ychinuki@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Fujita Health University
National Hospital Organization,
National Hospital Organization, Fukuoka National Hospital
Tokyo Medical and Dental University
Osaka University
Hiroshima University
Hyogo Prefectural Kakogawa Medical Center
Sagamihara National Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shimane University Hospital
Address 89-1, Enya-cyo, Izumo, 693-8501
Tel 0853-20-2259
Email kenkyu@med.shimane-u.ac.jp

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 島根大学(島根県)Shimane University (Shimane)
藤田保健衛生大学(愛知県)Fujita Health University (Aichi)
国立病院機構福岡病院(福岡県)National Hospital Organization, Fukuoka National Hospital (Fukuoka)
東京医科歯科大学(東京都)Tokyo Medical and Dental University (Tokyo)
大阪大学(大阪府)Osaka University (Osaka)
広島大学(広島県)Hiroshima University (Hiroshima)
兵庫県立加古川医療センター(兵庫県)Hyogo Prefectural Kakogawa Medical Center (Hyogo)
国立病院機構相模原病院(神奈川県)National Hospital Organization, Sagamihara National Hospital (Kanagawa)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 22 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
2016 Year 10 Month 31 Day
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 22 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028699

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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