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

January 27, 2009 updated by: University Hospital Muenster
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48149
        • University Clinics of Münster, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Randolf Brehler, senior MD, University Hospital Münster, Department of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 6, 2006

First Posted (ESTIMATE)

October 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBU_PAD_CU_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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