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

NCT00385372 | Completed

• 1 other identifier: BBU_PAD_CU_1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Urticaria; Angioedema

Keywords

low pseudoallergen diet; elimination diet; provocation diet; oral provocation; natural food ingredients; food additives; flavours

Interventions

elimination diet PROCEDURE

provocation diet PROCEDURE

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Clinics of Münster, Department of Dermatology

Münster, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 19137651 RESULT

MeSH Terms

Conditions

Urticaria; Angioedema

Interventions

Elimination Diets

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Randolf Brehler, senior MD

  University Hospital Münster, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 9, 2006
• Study Start: January 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 29, 2009

Record last verified: 2007-02

Locations

DE (1)