Edible Insect AllergyNCT07857187
Shrimp Sensitization and Allergy Among Patients With Edible Insect Allergy
A study testing Edible Insect Oral Food Challenge and White Shrimp Oral Food Challenge in people with Edible Insect Allergy and Shrimp Allergy, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aims to determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients aged ≥7 years with confirmed allergy to edible insects, including silkworm, bamboo worm, and palm weevil. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edible Insect Allergy, Shrimp Allergy, Shrimp Sensitization
- What is being tested?
- Edible Insect Oral Food Challenge and White Shrimp Oral Food Challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- 30 Aug 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged 7 years or older with a history of allergy to one or more of the following edible insects: silkworm, bamboo worm, or palm weevil.
- Patients with a history of an acute allergic reaction to silkworm, bamboo worm, or sago palm weevil who meet at least one of the following criteria:
- Development of clinical symptoms consistent with an acute allergic reaction within 2 hours after ingestion of the implicated edible insect, with evidence of sensitization confirmed by a positive skin prick test (SPT) to that edible insect; or
- A positive oral food challenge (OFC) to the edible insect previously associated with allergic symptoms (silkworm, bamboo worm, or sago palm weevil).
Who cannot join
- Scombroidosis (histamine fish poisoning).
- Currently receiving allergen immunotherapy.
- Unable to comply with the study follow-up schedule.
- Uncontrolled or severe asthma.
- Cardiovascular disease.
- Current use of beta-blockers, angiotensin-converting enzyme inhibitors (ACEIs), or angiotensin receptor blockers (ARBs).
- Developmental delay or intellectual disability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj hospital
Bangkok, Bangkoknoi, 10700
About this study
This study aims to determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients aged ≥7 years with confirmed allergy to edible insects, including silkworm, bamboo worm, and palm weevil. Participants undergo skin prick testing, specific IgE testing, ALEX2, immunoblot analysis, and risk-based oral food challenges to assess clinical cross-reactivity between edible insects and white shrimp and to help avoid unnecessary shrimp restriction.
Read the detailed description
A cross-sectional study of 19 patients aged ≥7 years with confirmed edible insect allergy. Participants will undergo comprehensive allergy assessment, including skin prick testing, specific IgE, tropomyosin, ALEX2, and immunoblot analysis. Risk-based oral food challenges to edible insects and white shrimp will be performed when clinically appropriate. The study aims to characterize shrimp sensitization, confirmed shrimp allergy, and clinical and molecular cross-reactivity between edible insects and shrimp
- Conditions
- Edible Insect Allergy, Shrimp Allergy, Shrimp Sensitization
- Being tested
- Edible Insect Oral Food Challenge, White Shrimp Oral Food Challenge
- Keywords
- edible insect allergy, shrimp allergy, silkworm allergy, tropomyosin, crossreactivity, oral food challenge, skin prick test, edible insect, Alex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edible Insect Oral Food ChallengeDietary supplement
Participants with suspected edible insect allergy who do not have a history of anaphylaxis or a previous positive oral food challenge will undergo an oral food challenge to the implicated edible insect (silkworm, bamboo worm, or palm weevil). The challenge will be performed using a graded protocol under medical supervision. Participants will be observed for at least 120 minutes after completion of the challenge.
White Shrimp Oral Food ChallengeDietary supplement
Participants with confirmed edible insect allergy will undergo a risk-based oral food challenge to white shrimp when clinically appropriate. Participants with previous tolerance will receive a single-step challenge with 100% of the age-appropriate serving, whereas those who have never consumed white shrimp or have a history of mild reactions will undergo a 4-step graded challenge (1/12, 1/6, 1/4, and 1/2 of the total serving). Participants with a history of white shrimp anaphylaxis or a white shrimp SPT wheal >22.5 mm will not undergo the challenge. Participants will be observed for at least 120 minutes after the challenge
| Study group | Role | What they receive |
|---|---|---|
| Patients with Edible Insect Allergy | Other | Patients aged ≥7 years with confirmed edible insect allergy will undergo allergy assessment, including skin prick testing, specific IgE testing, ALEX2, immunoblot analysis, and oral food challenges to edible insects and/or white shrimp when clinically appropriate. Receives: Dietary Supplement: Edible Insect Oral Food Challenge; Dietary Supplement: White Shrimp Oral Food Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients with a history of edible insect allergy.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Edible Insect 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Punchama Pacharn, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857187
- Sponsor's protocol ID
- MU-MOU249/2569
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dribin TE, Muraro A, Camargo CA Jr, Turner PJ, Wang J, Roberts G, Anagnostou A, Halken S, Liebermann J, Worm M, Zuberbier T, Sampson HA; GA(2)LEN Anaphylaxis Study Team. Anaphylaxis definition, overview, and clinical support tool: 2024 consensus report-a GA2LEN project. J Allergy Clin Immunol. 2025 Aug;156(2):406-417.e6. doi: 10.1016/j.jaci.2025.01.021. Epub 2025 Jan 27.
PubMed 39880313Jirapongsananuruk O, Sripramong C, Pacharn P, Udompunturak S, Chinratanapisit S, Piboonpocanun S, Visitsunthorn N, Vichyanond P. Specific allergy to Penaeus monodon (seawater shrimp) or Macrobrachium rosenbergii (freshwater shrimp) in shrimp-allergic children. Clin Exp Allergy. 2008 Jun;38(6):1038-47. doi: 10.1111/j.1365-2222.2008.02979.x.
PubMed 18498545Sripramong C, Visitsunthorn K, Srisuwatchari W, Pacharn P, Jirapongsananuruk O, Visitsunthorn N. Food sensitization and food allergy in allergic Thai patients from a tertiary care center in Thailand. Asian Pac J Allergy Immunol. 2022 Jun;40(2):147-154. doi: 10.12932/AP-210119-0475.
PubMed 31421663Bird JA, Leonard S, Groetch M, Assa'ad A, Cianferoni A, Clark A, Crain M, Fausnight T, Fleischer D, Green T, Greenhawt M, Herbert L, Lanser BJ, Mikhail I, Mustafa S, Noone S, Parrish C, Varshney P, Vlieg-Boerstra B, Young MC, Sicherer S, Nowak-Wegrzyn A. Conducting an Oral Food Challenge: An Update to the 2009 Adverse Reactions to Foods Committee Work Group Report. J Allergy Clin Immunol Pract. 2020 Jan;8(1):75-90.e17. doi: 10.1016/j.jaip.2019.09.029.
PubMed 31950914Jeong KY, Han IS, Lee JY, Park KH, Lee JH, Park JW. Role of tropomyosin in silkworm allergy. Mol Med Rep. 2017 May;15(5):3264-3270. doi: 10.3892/mmr.2017.6373. Epub 2017 Mar 24.
PubMed 28339033Pali-Scholl I, Meinlschmidt P, Larenas-Linnemann D, Purschke B, Hofstetter G, Rodriguez-Monroy FA, Einhorn L, Mothes-Luksch N, Jensen-Jarolim E, Jager H. Edible insects: Cross-recognition of IgE from crustacean- and house dust mite allergic patients, and reduction of allergenicity by food processing. World Allergy Organ J. 2019 Jan 26;12(1):100006. doi: 10.1016/j.waojou.2018.10.001. eCollection 2019.
PubMed 30937131Broekman H, Verhoeckx KC, den Hartog Jager CF, Kruizinga AG, Pronk-Kleinjan M, Remington BC, Bruijnzeel-Koomen CA, Houben GF, Knulst AC. Majority of shrimp-allergic patients are allergic to mealworm. J Allergy Clin Immunol. 2016 Apr;137(4):1261-1263. doi: 10.1016/j.jaci.2016.01.005. Epub 2016 Mar 1. No abstract available.
PubMed 269444042. Hidalgo, Ana Morales et al. Potential cross-reactivity between seafood and insects: Implications for allergen management. Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB55.
Rangkakulnuwat P, Sutham K, Lao-Araya M. Anaphylaxis: Ten-year retrospective study from a tertiary-care hospital in Asia. Asian Pac J Allergy Immunol. 2020 Mar;38(1):31-39. doi: 10.12932/AP-210318-0284.
PubMed 30447654
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shrimp Sensitization and Allergy Among Patients With Edible Insect Allergy
- ClinicalTrials.gov ID
- NCT07857187
- Acronym / sponsor ID
- MU-MOU249/2569
- Conditions
- Edible Insect Allergy, Shrimp Allergy, Shrimp Sensitization
- Keywords
- edible insect allergy, shrimp allergy, silkworm allergy, tropomyosin, crossreactivity, oral food challenge, skin prick test, edible insect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- 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.
This study aims to determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients aged ≥7 years with confirmed allergy to edible insects, including silkworm, bamboo worm, and palm weevil. Participants undergo skin prick testing, specific IgE testing, ALEX2, immunoblot analysis, and risk-based oral food challenges to assess clinical cross-reactivity between edible insects and white shrimp and to help avoid unnecessary shrimp restriction.
Detailed description
A cross-sectional study of 19 patients aged ≥7 years with confirmed edible insect allergy. Participants will undergo comprehensive allergy assessment, including skin prick testing, specific IgE, tropomyosin, ALEX2, and immunoblot analysis. Risk-based oral food challenges to edible insects and white shrimp will be performed when clinically appropriate. The study aims to characterize shrimp sensitization, confirmed shrimp allergy, and clinical and molecular cross-reactivity between edible insects and shrimp
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Edible Insect Allergy | Other | Dietary Supplement: Edible Insect Oral Food Challenge, Dietary Supplement: White Shrimp Oral Food ChallengePatients aged ≥7 years with confirmed edible insect allergy will undergo allergy assessment, including skin prick testing, specific IgE testing, ALEX2, immunoblot analysis, and oral food challenges to edible insects and/or white shrimp when clinically appropriate. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 7 years or older with a history of allergy to one or more of the following edible insects: silkworm, bamboo worm, or palm weevil.
- Patients with a history of an acute allergic reaction to silkworm, bamboo worm, or sago palm weevil who meet at least one of the following criteria:
Key exclusion criteria (7 listed)
- Scombroidosis (histamine fish poisoning).
- Currently receiving allergen immunotherapy.
- Unable to comply with the study follow-up schedule.
- Uncontrolled or severe asthma.
- Cardiovascular disease.
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 |
|---|---|---|
| Edible Insect Oral Food ChallengeParticipants with suspected edible insect allergy who do not have a history of anaphylaxis or a previous positive oral food challenge will undergo an oral food challenge to the implicated edible insect (silkworm, bamboo worm, or palm weevil). The challenge will be performed using a graded protocol under medical supervision. Participants will be observed for at least 120 minutes after completion of the challenge. | Dietary supplement | Patients with Edible Insect Allergy |
| White Shrimp Oral Food ChallengeParticipants with confirmed edible insect allergy will undergo a risk-based oral food challenge to white shrimp when clinically appropriate. Participants with previous tolerance will receive a single-step challenge with 100% of the age-appropriate serving, whereas those who have never consumed white shrimp or have a history of mild reactions will undergo a 4-step graded challenge (1/12, 1/6, 1/4, and 1/2 of the total serving). Participants with a history of white shrimp anaphylaxis or a white shrimp SPT wheal >22.5 mm will not undergo the challenge. Participants will be observed for at least 120 minutes after the challenge | Dietary supplement | Patients with Edible Insect Allergy |
Primary outcome
To determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients with a history of edible insect allergy.
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 39880313Dribin TE, Muraro A, Camargo CA Jr, Turner PJ, Wang J, Roberts G, Anagnostou A, Halken S, Liebermann J, Worm M, Zuberbier T, Sampson HA; GA(2)LEN Anaphylaxis Study Team. Anaphylaxis definition, overview, and clinical support tool: 2024 consensus report-a GA2LEN project. J Allergy Clin Immunol. 2025 Aug;156(2):406-417.e6. doi: 10.1016/j.jaci.2025.01.021. Epub 2025 Jan 27.
- Background: PubMed 18498545Jirapongsananuruk O, Sripramong C, Pacharn P, Udompunturak S, Chinratanapisit S, Piboonpocanun S, Visitsunthorn N, Vichyanond P. Specific allergy to Penaeus monodon (seawater shrimp) or Macrobrachium rosenbergii (freshwater shrimp) in shrimp-allergic children. Clin Exp Allergy. 2008 Jun;38(6):1038-47. doi: 10.1111/j.1365-2222.2008.02979.x.
- Background: PubMed 31421663Sripramong C, Visitsunthorn K, Srisuwatchari W, Pacharn P, Jirapongsananuruk O, Visitsunthorn N. Food sensitization and food allergy in allergic Thai patients from a tertiary care center in Thailand. Asian Pac J Allergy Immunol. 2022 Jun;40(2):147-154. doi: 10.12932/AP-210119-0475.
- Background: PubMed 31950914Bird JA, Leonard S, Groetch M, Assa'ad A, Cianferoni A, Clark A, Crain M, Fausnight T, Fleischer D, Green T, Greenhawt M, Herbert L, Lanser BJ, Mikhail I, Mustafa S, Noone S, Parrish C, Varshney P, Vlieg-Boerstra B, Young MC, Sicherer S, Nowak-Wegrzyn A. Conducting an Oral Food Challenge: An Update to the 2009 Adverse Reactions to Foods Committee Work Group Report. J Allergy Clin Immunol Pract. 2020 Jan;8(1):75-90.e17. doi: 10.1016/j.jaip.2019.09.029.
- Background: PubMed 28339033Jeong KY, Han IS, Lee JY, Park KH, Lee JH, Park JW. Role of tropomyosin in silkworm allergy. Mol Med Rep. 2017 May;15(5):3264-3270. doi: 10.3892/mmr.2017.6373. Epub 2017 Mar 24.
- Background: PubMed 30937131Pali-Scholl I, Meinlschmidt P, Larenas-Linnemann D, Purschke B, Hofstetter G, Rodriguez-Monroy FA, Einhorn L, Mothes-Luksch N, Jensen-Jarolim E, Jager H. Edible insects: Cross-recognition of IgE from crustacean- and house dust mite allergic patients, and reduction of allergenicity by food processing. World Allergy Organ J. 2019 Jan 26;12(1):100006. doi: 10.1016/j.waojou.2018.10.001. eCollection 2019.
- Background: PubMed 26944404Broekman H, Verhoeckx KC, den Hartog Jager CF, Kruizinga AG, Pronk-Kleinjan M, Remington BC, Bruijnzeel-Koomen CA, Houben GF, Knulst AC. Majority of shrimp-allergic patients are allergic to mealworm. J Allergy Clin Immunol. 2016 Apr;137(4):1261-1263. doi: 10.1016/j.jaci.2016.01.005. Epub 2016 Mar 1. No abstract available.
- Background2. Hidalgo, Ana Morales et al. Potential cross-reactivity between seafood and insects: Implications for allergen management. Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB55.
- Background: PubMed 30447654Rangkakulnuwat P, Sutham K, Lao-Araya M. Anaphylaxis: Ten-year retrospective study from a tertiary-care hospital in Asia. Asian Pac J Allergy Immunol. 2020 Mar;38(1):31-39. doi: 10.12932/AP-210318-0284.
- Individual participant dataSharing planned: Undecided
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.
Punchama Pacharn 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 Edible Insect Oral Food Challenge and White Shrimp Oral Food Challenge in people with Edible Insect Allergy and 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Punchama Pacharn (024197000 Ext. 5670, punchama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of shrimp sensitization and clinical shrimp allergy among patients with a history of edible insect allergy. (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07857187, which also lists 9 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 8 Oct 2026.