| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University Hospital Muenster |
| Information provided by: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00385372 |
Purpose
Patients with chronic urticaria undertake a five week elimination diet (pseudoallergen free diet). The efficacy of the diet will be determined by symptom score, by the use of rescue medication (oral antihistamines and glucocorticosteroids) and by a Quality of Life Questionnaire on week 0 and week 5. All patients with sufficient response (regarding the urticaria score) enter a second dietary part over six weeks, whereas a provocation diet is carried out. Each diet week a choice of pseudoallergen rich food is added, sorted by the type of pseudoallergens (e.g. biogenic amines, organic acids, flavours, additives). This study is conducted to investigate if the provocation diet could be a new diagnostic intervention to elucidate clinical relevant pseudoallergens.
| Condition | Intervention |
|
Urticaria Angioedema |
Procedure: elimination diet Procedure: provocation diet |
| MedlinePlus related topics: | Hives |
| Study Type: | Observational |
| Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
| Official Title: | Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | April 2007 |
Chronic urticaria is defined as a daily or almost daily spontaneous occurrence of wheals that cause itching and lasting for at least six weeks. If there is no indication of a possible eliciting agent and because approximately 70% of patients benefit from it, a low-pseudoallergen diet should be carried out for 5 weeks. Although the low-pseudoallergen diet is successful, no explanation of the underlying mechanisms exists. On DBPC oral provocation testing with known food additives, only a small amount of patients, who experienced remission after a low-pseudoallergen diet react with new wheals and/or angioedema. For this discrepancy, natural food ingredients and new food additives are included in the dietary diagnostic. The high amount of substances, which are administrated within oral provocation testing can not reflect a realistic diet situation. Often it is impossible to ingest corresponding amounts of foods to reach the same concentration such as the provocation amount. Recording change reactions between food ingredients and the individual metabolism of the patients, the "step by step" food provocation method reveals itself to be most effective. In addition, individual predilections, amounts and frequency of ingested foods, are taken into consideration.
Eligibility
| Ages Eligible for Study: | 7 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |||||
| University Clinics of Münster, Department of Dermatology | |||||
| Münster, Germany, 48149 | |||||
| University Hospital Muenster |
| Principal Investigator: | Randolf Brehler, senior MD | University Hospital Münster, Department of Dermatology |
More Information
| Study ID Numbers: | BBU_PAD_CU_1 |
| First Received: | October 6, 2006 |
| Last Updated: | February 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00385372 |
| Health Authority: | Germany: Ethics Commission |
|
|
|
|
|
|
