Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria

This study has been completed.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00385372
First received: October 6, 2006
Last updated: January 27, 2009
Last verified: February 2007
  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

Study Type: Interventional
Official Title: Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Estimated Enrollment: 150
Study Start Date: January 2005
Study Completion Date: April 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00385372     History of Changes
Other Study ID Numbers: BBU_PAD_CU_1
Study First Received: October 6, 2006
Last Updated: January 27, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
low pseudoallergen diet
elimination diet
provocation diet
oral provocation
natural food ingredients
food additives
flavours

Additional relevant MeSH terms:
Angioedema
Urticaria
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014