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NCT04552522

Immunological Response After Shrimp Oral Immunotherapy Treatment

Completed NA Results posted Last updated 3 April 2026
What this trial tests

NA trial testing shrimp allergy with intend to eat shrimp in Allergy to Shrimp in 20 participants. Completed in 30 December 2024.

Timeline
28 August 2020
Primary endpoint
31 October 2024
30 December 2024

Quick facts

Lead sponsorMahidol University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment20
Start date28 August 2020
Primary completion31 October 2024
Estimated completion30 December 2024
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Mahidol University

Who can join

Adults 12 to 40, any sex, with Allergy to Shrimp or Immunotherapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Eliciting Dose of Shrimp During Oral Food Challenge Primary · Baseline and 12 months

Change in the eliciting dose (ED) of shrimp protein during oral food challenge from baseline to 12 months in participants with shrimp allergy undergoing shrimp oral immunotherapy compared with avoidance.

GroupValue95% CI
Shrimp Allergy With Intend to Eat Shrimp32331400 – 9900
Shrimp Allergy With Avoid Shrimp25-50 – 200

Adverse events — posted to ClinicalTrials.gov

Time frame: from enrollment until end of 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Shrimp Allergy With Intend to Eat Shrimp
Serious: 1/10 (10%)
Deaths: 0/10
Shrimp Allergy With Avoid Shrimp
Serious: 4/10 (40%)
Deaths: 0/10

Serious adverse events (1 terms)

ReactionSystemShrimp Allergy With Intend…Shrimp Allergy With Avoid …
anaphylaxisRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: anaphylaxis.

Data from ClinicalTrials.gov NCT04552522 adverse events section.

Sponsor's own description

Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advances in Shellfish Allergy Therapy: From Current Approaches to Future Strategies.
    Heidari S, Ruethers T, Karnaneedi S, Yin LWS, et al · · 2025 · cited 4× · PMID 40668267 · DOI 10.1007/s12016-025-09077-8

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Other Mahidol University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04552522.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing