UrticariaNCT00385372
Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
A study testing elimination diet and provocation diet in people with Urticaria and Angioedema, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 80 years
- Conditions the study is for
- Urticaria, Angioedema
- What is being tested?
- elimination diet and provocation diet
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinics of Münster, Department of Dermatology
Münster, 48149
About this study
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.
Read the 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.
- Conditions
- Urticaria, Angioedema
- Being tested
- elimination diet, provocation diet
- Keywords
- low pseudoallergen diet, elimination diet, provocation diet, oral provocation, natural food ingredients, food additives, flavours
- Medical subject headings
- Urticaria, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elimination dietProcedure or surgery
provocation dietProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Randolf Brehler, senior MD, Principal investigator, University Hospital Münster, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385372
- Sponsor's protocol ID
- BBU_PAD_CU_1
- Status last verified
- Feb 2007
- First submitted
- 6 Oct 2006
- Last updated
- 29 Jan 2009
- Results posted
- No
Publications
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.
PubMed 19137651
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria
- ClinicalTrials.gov ID
- NCT00385372
- Acronym / sponsor ID
- BBU_PAD_CU_1
- Conditions
- Urticaria, Angioedema
- Keywords
- low pseudoallergen diet, elimination diet, provocation diet, oral provocation, natural food ingredients, food additives, flavours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elimination diet | Procedure or surgery | – |
| provocation diet | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Results publication: PubMed 19137651Bunselmeyer 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randolf Brehler, senior MD principal investigator
University Hospital Münster, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elimination diet and provocation diet in people with Urticaria and Angioedema, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.