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

Primary Purpose

Urticaria, Angioedema

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
elimination diet
provocation diet
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Urticaria focused on measuring low pseudoallergen diet, elimination diet, provocation diet, oral provocation, natural food ingredients, food additives, flavours

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Clinics of Münster, Department of Dermatology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 6, 2006
Last Updated
January 27, 2009
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT00385372
Brief Title
Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
Official Title
Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria, Angioedema
Keywords
low pseudoallergen diet, elimination diet, provocation diet, oral provocation, natural food ingredients, food additives, flavours

7. Study Design

Study Phase
Not Applicable
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
elimination diet
Intervention Type
Procedure
Intervention Name(s)
provocation diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randolf Brehler, senior MD
Organizational Affiliation
University Hospital Münster, Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinics of Münster, Department of Dermatology
City
Münster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19137651
Citation
Bunselmeyer B, Laubach HJ, Schiller M, Stanke M, Luger TA, Brehler R. Incremental build-up food challenge--a new diagnostic approach to evaluate pseudoallergic reactions in chronic urticaria: a pilot study: stepwise food challenge in chronic urticaria. Clin Exp Allergy. 2009 Jan;39(1):116-26. doi: 10.1111/j.1365-2222.2008.03110.x.
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Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria

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