UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024951 |
|---|---|
| Receipt number | 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 | 2025/05/30 09:42:27 |
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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 | 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
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
ychinuki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Under the analysis
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
| 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
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028699
