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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| University of Nebraska Lincoln | OTHER |
| Region Hovedstadens Apotek | OTHER_GOV |
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In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole | Active Comparator | patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge |
|
| Placebo | Sham Comparator | patients will take Mannitol, in capsules, once a day, during five days before walnut challenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| amount of walnuts that induces an allergic reaction assessed in milligram | The amount of walnut which induces an allergic reaction in walnut allergic patients will be assessed in milligram by titrated challenges under concommitant intake of therapeutic doses of omeprazole versus placebo | up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
• Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal
corticosteroids systemically (2 weeks)
antihistamines (3 days) except hydroxyzine (10 days)
ketotifen (2 weeks)
betablocker (1 day)
angiotensin converting enzyme (ACE) inhibitors (2 days)
omalizumab (2 months)
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| Name | Affiliation | Role |
|---|---|---|
| Clare Mills, Prof, PhD | University Manchester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Madrid | Spain | ||||
| University Hospital Zurich |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| University of Manchester |
| OTHER |
| Hospital San Carlos, Madrid | OTHER |
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| Placebo | Drug | patients with walnut allergy will be exposed during 5 days before food challenge with Placebo |
|
|
| Zurich |
| 8091 |
| Switzerland |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |