UMIN ID: UMIN000024951
Registered date:22/11/2016
Phase II-multicenter clinical trial of hypoallergenic wheat 1BS-18 Hokushin
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Wheat allergy |
| Date of first enrollment | 2016/10/31 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. |
Outcome(s)
| Primary Outcome | Decrease in reactivity to wheat allergens of basophil activating test. |
|---|---|
| Secondary Outcome | Rate of 0 score of subjective and objective symptoms after ingesting the 1BS-18 Hokushin bread. Evaluation is performed from 0 to 12 weeks. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Shimane University |
|---|---|
| Secondary 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 |
| Source(s) of Monetary Support | Grant-in-Aid for Scientific Research |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuko Chinuki |
| Address | Enya 89-1, Izumo, Shimane 693-8501, Japan Japan 6938501 |
| Telephone | 0853-20-2210 |
| ychinuki@med.shimane-u.ac.jp | |
| Affiliation | Shimane University Department of Dermatology |
| scientific contact | |
| Name | Yuko Chinuki |
| Address | Enya 89-1, Izumo, Shimane 693-8501, Japan Japan |
| Telephone | 0853-20-2210 |
| emorita@med.shimane-u.ac.jp | |
| Affiliation | Shimane University Department of Dermatology |