Wheat allergy
Conditions
Interventions
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: 3
Sponsors
Shimane University
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
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in reactivity to wheat allergens of basophil activating test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of 0 score of subjective and objective symptoms after ingesting the 1BS-18 Hokushin bread. Evaluation is performed from 0 to 12 weeks. | — |
Countries
Japan
Contacts
Public ContactYuko Chinuki
Shimane University Department of Dermatology
Outcome results
None listed