Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
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| ClinicalTrials.gov Identifier: NCT00385372 |
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Recruitment Status :
Completed
First Posted : October 9, 2006
Last Update Posted : January 29, 2009
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Sponsor:
University Hospital Muenster
Information provided by:
University Hospital Muenster
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Urticaria Angioedema | Procedure: elimination diet Procedure: provocation diet | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 150 participants |
| Official Title: | Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria |
| Study Start Date : | January 2005 |
| Actual Primary Completion Date : | January 2007 |
| Actual Study Completion Date : | April 2007 |
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| Ages Eligible for Study: | 7 Years to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- signed informed consent
- chronic urticaria (duration: at least 6 weeks)
- patients who suffered from urticaria and/or angio oedema at least once a week for a duration of at least 4 weeks)
- Males and females, age between 7 and 80 years
- inpatients and outpatients
- oral antihistamines and glucocorticosteroids are allowed as concomitant medication (if needed)
Exclusion Criteria:
- pregnant or breastfeeding woman
- patients suffering from diabetes mellitus
- patients with cachexia
- known food allergies of food which will be administrated within the elimination diet (e.g. milk, cereals)
- isolated urticaria with known aetiology (e.g. physical urticaria, aquagene urticaria, urticaria factitia, cholinergic urticaria), Urticaria pigmentosa mastocytoses)
- patients, seemed to be uncompliant under suspicion of the investigator
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385372
Locations
| Germany | |
| University Clinics of Münster, Department of Dermatology | |
| Münster, Germany, 48149 | |
Sponsors and Collaborators
University Hospital Muenster
Investigators
| Principal Investigator: | Randolf Brehler, senior MD | University Hospital Münster, Department of Dermatology |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00385372 |
| Other Study ID Numbers: |
BBU_PAD_CU_1 |
| First Posted: | October 9, 2006 Key Record Dates |
| Last Update Posted: | January 29, 2009 |
| Last Verified: | February 2007 |
Keywords provided by University Hospital Muenster:
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low pseudoallergen diet elimination diet provocation diet oral provocation |
natural food ingredients food additives flavours |
Additional relevant MeSH terms:
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Angioedema Urticaria Chronic Urticaria Skin Diseases, Vascular Skin Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Vascular Diseases Cardiovascular Diseases |