Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385372
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2006-10-06
Brief Title:
Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None