Peanut HypersensitivityNCT00243555
Development of an Algorithm to Better Predict Clinical Responsiveness to Peanut
An observational study of Peanut Hypersensitivity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to develop a tool to better predict clinical allergy to peanut, so that those who are skin test positive but non allergic will not have to unnecessarily avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion challenge, and treated appropriately Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peanut Hypersensitivity
- What is being tested?
- allergy skin testing and venepuncture
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2002to not given
- Phase
- Observational
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 5 years of age and older
- Informed consent (Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.)
- Free of any clinically significant disease, such as uncontrolled asthma, which may interfere with study evaluations
- Group 1:
- skin test positive to peanut
- documented clinical history of peanut allergy. A documented clinical history may include symptoms such as hives,swelling of the mouth or tongue, throat closing sensation, shortness of breath, wheezing, lightheadedness, anaphylaxis.
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- Group 2:
- Positive skin test to peanut
- History of being able to tolerate peanut exposure without problems
- Group 3:
- Positive skin test to peanut
- No known ingestion of peanut
- Group 4:
- Negative skin test to peanut
- Negative skin test to other food and environmental allergens
- Able to tolerate peanut exposure without problems
Who cannot join
- Women who are pregnant or nursing
- use of antihistamines or decongestant therapy four days prior to clinic visit
- use of nasal or inhaled corticosteroid in the 1 month period prior to clinic visit
- use of non-steroidal anti-inflammatory drugs (NSAIDS) in the week prior to clinic visit
- Moderate or severe/ uncontrolled asthma (defined as the use of more than 4 puffs of ventolin per day, not including prophylactic medications prior to exercise)
- Symptomatic allergic rhinitis
Show all 10Show fewer
- Patients who had an acute allergic reaction to food, drugs, and bee sting in the 1 month period prior to clinic visit
- Use of an epi-pen during the past month
- respiratory infection one month prior to clinic visit
- immunotherapy
Trial locations and contacts
1 site in 1 country.
Andrea Marin, MD contact
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences Corporation, McMaster Site
Hamilton, Ontario, L8N 3Z5
Marie Townsend, 905-525-9140 ext. 22465, hsresadm@mcmaster.ca
Deidre L. Henne, 905-521-2100 ext. 74595, henne@hhsc.ca
About this study
Official title: Molecular Analysis of Immuno-Regulatory Genes Expressed by Mononuclear Cells From Peanut Skin Test Positive Individuals With and Without a History of Peanut Ingestion
The purpose of this study is to develop a tool to better predict clinical allergy to peanut, so that those who are skin test positive but non allergic will not have to unnecessarily avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion challenge, and treated appropriately
Read the detailed description
Peanut allergy occurs in about 1% of the population. Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions. Currently the only available treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidentally ingest peanut. Accurate diagnosis is critical, yet often problematic. Current diagnostic methods such as skin and blood tests cannot predict definitively who is allergic and can result in patients being falsely labeled. One such group is children who have never been exposed to peanut as a means of preventing allergy, yet have positive skin tests. The only means of definitively diagnosing this group is with an oral peanut challenge, a potentially risky procedure. Previous studies have demonstrated differences in certain genes and growth factors between peanut allergic and non-allergic individuals. The proposed study has 2 phases. The first phase, almost completed, examines expression of genes and growth factors in defined groups of peanut allergic and non-allergic individuals which should help distinguish between these groups. Peripheral blood mononuclear cells from each patient will be cultured and analyzed for a variety of growth factors and other immune molecules, including mRNA, thought to be important in allergy.
The second phase of this study will involve feeding peanut to individuals with positive skin tests, who have never been peanut exposed. Their blood will be examined before and after the challenge using information from Part 1, and results will be correlated with their ability to tolerate peanut on feeding. This study should enable us to better predict who is truly peanut allergic.
There are four groups of patients in this study. Group 1 consists of individuals who are allergic to peanut. This group of individuals will have a positive skin test to peanut and a previous allergi reaction to peanut. Group 2 consists of indivduals who have a positive skin test to peanut but who are able to ingest peanuts without problems. Group 3 consists of individuals who have a positive skin test to peanut but who have no known ingestion of peanut and who have avoided peanut lifelong for whatever reason (e.g. a strong family history of peanut allergy). Lastly, group 4 consists of control subjects who are negative to the peanut skin test and are able to tolerate peanut without problems.
- Conditions
- Peanut Hypersensitivity
- Being tested
- allergy skin testing, venepuncture
- Keywords
- peanut hypersensitivity, chemokines, cytokines, RNA,messenger, monocytes
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergy skin testingProcedure or surgery
venepunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peanut HypersensitivityStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Food Allergy Initiative, AllerGen NCE Inc.
- Investigators
- Susan Waserman, MSc, MD, FRCPC, Principal investigator, Hamilton Health Sciences Corporation, McMaster Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243555
- Sponsor's protocol ID
- 2002H05183
- Other IDs
- FP-2005-25
- Status last verified
- Sep 2006
- First submitted
- 20 Oct 2005
- Last updated
- 1 Feb 2007
- Results posted
- No
Publications
Heaton T, Rowe J, Turner S, Aalberse RC, de Klerk N, Suriyaarachchi D, Serralha M, Holt BJ, Hollams E, Yerkovich S, Holt K, Sly PD, Goldblatt J, Le Souef P, Holt PG. An immunoepidemiological approach to asthma: identification of in-vitro T-cell response patterns associated with different wheezing phenotypes in children. Lancet. 2005 Jan 8-14;365(9454):142-9. doi: 10.1016/S0140-6736(05)17704-6.
PubMed 15639296Turcanu V, Maleki SJ, Lack G. Characterization of lymphocyte responses to peanuts in normal children, peanut-allergic children, and allergic children who acquired tolerance to peanuts. J Clin Invest. 2003 Apr;111(7):1065-72. doi: 10.1172/JCI16142.
PubMed 12671056Umetsu DT. Revising the immunological theories of asthma and allergy. Lancet. 2005 Jan 8-14;365(9454):98-100. doi: 10.1016/S0140-6736(05)17714-9. No abstract available.
PubMed 15639274Kagan RS, Joseph L, Dufresne C, Gray-Donald K, Turnbull E, Pierre YS, Clarke AE. Prevalence of peanut allergy in primary-school children in Montreal, Canada. J Allergy Clin Immunol. 2003 Dec;112(6):1223-8. doi: 10.1016/j.jaci.2003.09.026.
PubMed 14657887Sampson HA. Update on food allergy. J Allergy Clin Immunol. 2004 May;113(5):805-19; quiz 820. doi: 10.1016/j.jaci.2004.03.014.
PubMed 15131561Roberts G, Lack G. Diagnosing peanut allergy with skin prick and specific IgE testing. J Allergy Clin Immunol. 2005 Jun;115(6):1291-6. doi: 10.1016/j.jaci.2005.02.038.
PubMed 15940149van Odijk J, Ahlstedt S, Bengtsson U, Borres MP, Hulthen L. Double-blind placebo-controlled challenges for peanut allergy the efficiency of blinding procedures and the allergenic activity of peanut availability in the recipes. Allergy. 2005 May;60(5):602-5. doi: 10.1111/j.1398-9995.2005.00666.x.
PubMed 15813803
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Immuno-Regulatory Genes Expressed by Mononuclear Cells From Peanut Skin Test Positive Individuals With and Without a History of Peanut Ingestion
- ClinicalTrials.gov ID
- NCT00243555
- Acronym / sponsor ID
- 2002H05183
- Conditions
- Peanut Hypersensitivity
- Keywords
- peanut hypersensitivity, chemokines, cytokines, RNA,messenger, monocytes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Food Allergy Initiative, AllerGen NCE Inc.
- Study start
- Sep 2002
- First posted
- 24 Oct 2005 (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.
The purpose of this study is to develop a tool to better predict clinical allergy to peanut, so that those who are skin test positive but non allergic will not have to unnecessarily avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion challenge, and treated appropriately
Detailed description
Peanut allergy occurs in about 1% of the population. Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions. Currently the only available treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidentally ingest peanut. Accurate diagnosis is critical, yet often problematic. Current diagnostic methods such as skin and blood tests cannot predict definitively who is allergic and can result in patients being falsely labeled. One such group is children who have never been exposed to peanut as a means of preventing allergy, yet have positive skin tests. The only means of definitively diagnosing this group is with an oral peanut challenge, a potentially risky procedure. Previous studies have demonstrated differences in certain genes and growth factors between peanut allergic and non-allergic individuals. The proposed study has 2 phases. The first phase, almost completed, examines expression of genes and growth factors in defined groups of peanut allergic and non-allergic individuals which should help distinguish between these groups. Peripheral blood mononuclear cells from each patient will be cultured and analyzed for a variety of growth factors and other immune molecules, including mRNA, thought to be important in allergy.
The second phase of this study will involve feeding peanut to individuals with positive skin tests, who have never been peanut exposed. Their blood will be examined before and after the challenge using information from Part 1, and results will be correlated with their ability to tolerate peanut on feeding. This study should enable us to better predict who is truly peanut allergic.
There are four groups of patients in this study. Group 1 consists of individuals who are allergic to peanut. This group of individuals will have a positive skin test to peanut and a previous allergi reaction to peanut. Group 2 consists of indivduals who have a positive skin test to peanut but who are able to ingest peanuts without problems. Group 3 consists of individuals who have a positive skin test to peanut but who have no known ingestion of peanut and who have avoided peanut lifelong for whatever reason (e.g. a strong family history of peanut allergy). Lastly, group 4 consists of control subjects who are negative to the peanut skin test and are able to tolerate peanut without problems.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 5 years of age and older
- Informed consent (Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.)
- Free of any clinically significant disease, such as uncontrolled asthma, which may interfere with study evaluations
- skin test positive to peanut
- documented clinical history of peanut allergy. A documented clinical history may include symptoms such as hives,swelling of the mouth or tongue, throat closing sensation, shortness of breath, wheezing, lightheadedness, anaphylaxis.
Key exclusion criteria (10 listed)
- Women who are pregnant or nursing
- use of antihistamines or decongestant therapy four days prior to clinic visit
- use of nasal or inhaled corticosteroid in the 1 month period prior to clinic visit
- use of non-steroidal anti-inflammatory drugs (NSAIDS) in the week prior to clinic visit
- Moderate or severe/ uncontrolled asthma (defined as the use of more than 4 puffs of ventolin per day, not including prophylactic medications prior to exercise)
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 |
|---|---|---|
| allergy skin testing | Procedure or surgery | – |
| venepuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2007.
- Background: PubMed 15639296Heaton T, Rowe J, Turner S, Aalberse RC, de Klerk N, Suriyaarachchi D, Serralha M, Holt BJ, Hollams E, Yerkovich S, Holt K, Sly PD, Goldblatt J, Le Souef P, Holt PG. An immunoepidemiological approach to asthma: identification of in-vitro T-cell response patterns associated with different wheezing phenotypes in children. Lancet. 2005 Jan 8-14;365(9454):142-9. doi: 10.1016/S0140-6736(05)17704-6.
- Background: PubMed 12671056Turcanu V, Maleki SJ, Lack G. Characterization of lymphocyte responses to peanuts in normal children, peanut-allergic children, and allergic children who acquired tolerance to peanuts. J Clin Invest. 2003 Apr;111(7):1065-72. doi: 10.1172/JCI16142.
- Background: PubMed 15639274Umetsu DT. Revising the immunological theories of asthma and allergy. Lancet. 2005 Jan 8-14;365(9454):98-100. doi: 10.1016/S0140-6736(05)17714-9. No abstract available.
- Background: PubMed 14657887Kagan RS, Joseph L, Dufresne C, Gray-Donald K, Turnbull E, Pierre YS, Clarke AE. Prevalence of peanut allergy in primary-school children in Montreal, Canada. J Allergy Clin Immunol. 2003 Dec;112(6):1223-8. doi: 10.1016/j.jaci.2003.09.026.
- Background: PubMed 15131561Sampson HA. Update on food allergy. J Allergy Clin Immunol. 2004 May;113(5):805-19; quiz 820. doi: 10.1016/j.jaci.2004.03.014.
- Background: PubMed 15940149Roberts G, Lack G. Diagnosing peanut allergy with skin prick and specific IgE testing. J Allergy Clin Immunol. 2005 Jun;115(6):1291-6. doi: 10.1016/j.jaci.2005.02.038.
- Background: PubMed 15813803van Odijk J, Ahlstedt S, Bengtsson U, Borres MP, Hulthen L. Double-blind placebo-controlled challenges for peanut allergy the efficiency of blinding procedures and the allergenic activity of peanut availability in the recipes. Allergy. 2005 May;60(5):602-5. doi: 10.1111/j.1398-9995.2005.00666.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.
Andrea Marin, MD contact
Susan Waserman, MSc, MD, FRCPC principal investigator
Hamilton Health Sciences Corporation, McMaster Site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Hypersensitivity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 16 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Feb 2007. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Marin, MD (905-521-2100 ext. 75642), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243555, which also lists 7 linked publications.
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 1 Feb 2007.