Food (Shrimp) AllergyNCT01619605
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
A study testing shrimp challenge in people with Food (Shrimp) Allergy, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Food (Shrimp) Allergy
- What is being tested?
- shrimp challenge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2006to Jun 2008
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a history of shrimp allergy
Who cannot join
- severe anaphylactic reaction from seafood
- pregnancy
- underlying diseases such as cardiovascular, hepatobiliary, and renal diseases
- on systemic corticosteroid or β-blocking agents
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.
Read the detailed description
The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.
Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.
Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.
In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.
- Conditions
- Food (Shrimp) Allergy
- Being tested
- shrimp challenge
- Keywords
- tryptases, anaphylaxis, shrimp allergy
- Medical subject headings
- Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shrimp challengeProcedure or surgery
Also called open food challenge
Patients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group
| Study group | Role | What they receive |
|---|---|---|
| Shrim | Experimental | Not described Receives: Procedure: shrimp challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Serum tryptases
Measured: baseline and 60 minutes after the onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food (Shrimp) AllergyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Orathai Piboonpocanun, Assoc.Prof., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619605
- Sponsor's protocol ID
- 669/2551(EC4)
- Status last verified
- Jun 2012
- First submitted
- 12 Jun 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
- ClinicalTrials.gov ID
- NCT01619605
- Acronym / sponsor ID
- 669/2551(EC4)
- Conditions
- Food (Shrimp) Allergy
- Keywords
- tryptases, anaphylaxis, shrimp allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Jun 2012 (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 was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.
Detailed description
The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.
Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.
Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.
In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shrim | Experimental | Procedure: shrimp challenge |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- a history of shrimp allergy
Key exclusion criteria (4 listed)
- severe anaphylactic reaction from seafood
- pregnancy
- underlying diseases such as cardiovascular, hepatobiliary, and renal diseases
- on systemic corticosteroid or β-blocking agents
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 |
|---|---|---|
| shrimp challengeAlso: open food challengePatients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group | Procedure or surgery | Shrim |
Primary outcome
Change of Serum tryptases
Time frame: baseline and 60 minutes after the onset of symptoms
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 15 Jun 2012.
Related trials for Food (Shrimp) Allergy
Recruiting
Shrimp Sensitization and Allergy Among Patients With Edible Insect Allergy
Edible Insect Allergy, Shrimp Allergy
Recruiting
Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy
Food Hypersensitivity, Shellfish Allergy
Active, not recruitingPhase 1
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Food Allergy
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.
Orathai Piboonpocanun, Assoc.Prof. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shrimp challenge in people with Food (Shrimp) Allergy, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 4 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 15 Jun 2012. 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 Thailand. 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.
What does the primary outcome measure?
Change of Serum tryptases (time frame: baseline and 60 minutes after the onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2012.