Immunological Response After Shrimp Oral Immunotherapy Treatment

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years - 40 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 12 - 40 years old.

- History of Immunoglobulin E-mediated shrimp allergy > 3 episode/year or disturb quality of life.

- Positive oral food challenge test for shrimp.

Exclusion Criteria:

- History of shrimp anaphylaxis (include cardiovascular or neurological symptoms) - Shellfish dependent exercise induced anaphylaxis.

- History of cardiovascular disease, uncontrolled asthma, severe atopic dermatitis.

- History of Beta-blocker, Angiotensin-converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04552522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mahidol University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Punchama Pacharn, MD
Principal Investigator Affiliation	Mahidol University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Thailand
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergy to Shrimp, Immunotherapy

Additional Details

All subject in this study were sensitized to shrimp. All patient was clinically evaluated, with focus on shrimp allergy by medical history, medical examination and gold standard oral food challenge test. Compare oral immunotherapy to shrimp and shrimp avoidance. Blood sample was taken for baseline determination of immunoglobulin E antibodies to shrimp. The primary outcome was the specific immunoglobulin E antibodies to shrimp,Immunoglobulin G4 and immunoblot analysis in case that oral immunotherapy.

Arms & Interventions

Arms

Experimental: Shrimp allergy with Intend to eat shrimp

Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp

No Intervention: Shrimp allergy with avoid shrimp

Case shrimp allergy with avoid shrimp

Interventions

Other: - shrimp allergy with intend to eat shrimp

shrimp allergy with intend to eat shrimp and treat with oral immunotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Siriraj Hospital, Bangkoknoi, Bangkok, Thailand

Status

Address

Siriraj Hospital

Bangkoknoi, Bangkok, 10700

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