Skip to main content
OpenTrials
Completed

NCT Number: NCT00385372

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinics of Münster, Department of Dermatology

Münster, 48149, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

elimination diet

Procedure

provocation diet

Procedure

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 9, 2006
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.