CLINICAL TRIAL

Cashew or Shrimp Oral Immunotherapy for Hypersensitivity

Waitlist Available · < 65 · All Sexes · Mountain View, CA

This study is evaluating whether a treatment for allergies may be effective for individuals with allergies to cashew or shrimp.

See full description

About the trial for Hypersensitivity

Eligible Conditions
Allergy to Shrimp · Allergy;Food · Food Hypersensitivity · Hypersensitivity · Allergy to Cashew Nut (Disorder)

Treatment Groups

This trial involves 2 different treatments. Cashew Or Shrimp Oral Immunotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cashew or Shrimp Oral Immunotherapy
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject and/or parent guardian must be able to understand and provide informed consent
Age 7 through 55 years (inclusive)
Clinical history of allergy to cashew or shrimp-containing foods
Serum IgE to cashew or shrimp of ≥0.35 kUA/L [determined by UniCAPTM within the past 12 months] and/or a SPT to cashew or shrimp ≥3 mm compared to control
Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
Written informed consent from adult participants
Written informed consent from parent/guardian for minor participants
Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
Use of effective birth control by female participants of child-bearing potential.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cashew or Shrimp Oral Immunotherapy will improve 1 primary outcome and 2 secondary outcomes in patients with Hypersensitivity. Measurement will happen over the course of 58 weeks.

Compare changes in the following measures in CD4+CD28+ allergen specific (CD154+)
58 WEEKS
Compare changes in the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at week 52 and week 58 between those who achieved sustained unresponsiveness (SU) vs those desensitized but SU failures vs those who did not pass the desensitization DBPCFC at week 52 Levels of IFN-gamma Levels of IL-4 Receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells Levels of IL-10 Levels of TGF beta Levels of GPR15 Levels of CCR4+ Levels of CRTh2
58 WEEKS
Compare changes in expression of CD28+ allergen specific (CD154+)
64 WEEKS
Compare changes in expression of CD28+ allergen specific (CD154+) T-cells over multiple time points from baseline to week 58 and week 64 between those with sustained unresponsiveness (SU) vs those desensitized but SU failures vs those who did not pass DBPCFC.
64 WEEKS
Change in expression of CD28 in the CD4+ allergen specific (CD154+)
1 YEAR
Change in expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at 52 weeks relative to baseline values between those who do and do not tolerate a cumulative of 2043 mg in the DBPCFC at week 52.
1 YEAR

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cashew or shrimp oral immunotherapy?

Oral sublingual immunotherapy appears to work in the clinical setting and merits further research. To our knowledge this is the first report of an oral immunotherapy protocol for cashew and shrimp allergens in a large population that could potentially have relevance to the treatment of other OIT protocols.

Anonymous Patient Answer

What are the common side effects of cashew or shrimp oral immunotherapy?

Cashew or shrimp allergens are potential causes of a severe skin reaction. This reaction can be life threatening. Therefore, patients with a history of peanut allergy should avoid consuming shrimp or cashew nuts as well as raw shellfish.

Anonymous Patient Answer

What causes hypersensitivity?

There are multiple causes of hypersensitivity, some of which can be treated and corrected medically. In addition to the patient's history, testing of family members for their histocompatibility can provide insight for these causes. To prevent them, a physician should advise against taking the medicines of a prescribed type. The first step should be to discontinue these medications. The hypersensitivity can then be corrected by applying multiple steps of medication and an elimination of a specific type of hypersensitivity.

Anonymous Patient Answer

What are common treatments for hypersensitivity?

The most common treatments for drug hypersensitivity include avoidance, oral or intravenous steroids, and intravenous immunoglobulin (IVIG), as indicated by a previous history of anaphylaxis.

Anonymous Patient Answer

What is hypersensitivity?

Recent findings we found hypoalgesia in the TII in patients with hypersensitivity disorders and allodynia in patients with other clinical diagnoses. Hypoalgesia increased and allodynia decreased with no significant correlation to hypersensitivity, suggesting that other etiology is required for both responses.

Anonymous Patient Answer

What are the signs of hypersensitivity?

Symptoms like pain and itching of the eyes, mouth, skin or around the mouth with or without skin rash and dermatitis are all indications of hypersensitivity symptoms. It is important to realize that patients with allergy symptoms may have many different health problems, such as allergy-mediated asthma, asthma without atopy, or a drug reaction. This may take time to diagnose properly as many allergy symptoms overlap with more common health problems. Allergic diseases such as asthma must be suspected when a patient presents with breathing difficulties, shortness of breath, or chest pain. The differential diagnosis of the symptoms is critical to ensure timely care.

Anonymous Patient Answer

How many people get hypersensitivity a year in the United States?

The prevalence of all-cause hypersensitivity was estimated to be 6.4% (range, 2.5%-13.0%) in the U.S. general population, of which 5.3% was allergic rhinitis. The prevalences were similar between subpopulations defined by age, sex, race, and geographic location. Over half (53.8%) of persons with a hypersensitivity reaction received emergency care because they were unresponsive to standard care and/or were hospitalized. A significant proportion of allergic patients will be admitted to an emergency department.

Anonymous Patient Answer

Can hypersensitivity be cured?

Currently no effective therapies exist to cure or prevent the hypersensitivity syndromes of allergies and asthma. Allergic patients who are treated before the diagnosis of a hypersensitivity disease often have a reduced risk of developing a hypersensitivity, but the risk of developing a hypersensitivity disease is still elevated.

Anonymous Patient Answer

Have there been other clinical trials involving cashew or shrimp oral immunotherapy?

Cashew and shrimp oral immunotherapy trials with cashew and shrimp allergens are ongoing in the US, US/Canada and Europe. It is recommended that future trials report their results in detail and that additional studies be undertaken. In the US/ Canada, the results of the placebo-controlled trials that were performed will not suffice as evidence to support their routine use. The efficacy of the products in reducing cross-reactions needs to be investigated. Until all the products (casein, peanut, tree nut, and seafood) demonstrated the efficacy in the clinical trials, it is not recommended for routine use.

Anonymous Patient Answer

Has cashew or shrimp oral immunotherapy proven to be more effective than a placebo?

Oral immunoallergic reaction to cashew or shrimp was more frequent in the study group than in those receiving only a placebo only in the cashew sensitivity group. Thus, the oral immunotherapy with cashew or shrimp has proven to be more effective than a placebo in children with cashew hypersensitivity.

Anonymous Patient Answer

What is the latest research for hypersensitivity?

Today, many physicians use the latest medical research when determining whether a patient should receive a specific treatment or not. Yet, this type of research is not always completely objective. The best approach for both patients and physicians will result when both the patient and physician are informed and working together.

Anonymous Patient Answer

Who should consider clinical trials for hypersensitivity?

The clinical trial power (PS power) of allergists in the US is estimated to be approximately 0.5. While the clinical practice guidelines suggest that a minimum PS of 0.5 and a minimum PS for immunotherapy of 0.75, the majority of US allergists do not conduct clinical trials for immunotherapy. The data indicated that, among those allergists who conduct clinical trials for immunotherapy, nearly all performed a clinical trial power analysis (PS power ≥ 0.7).

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Hypersensitivity by sharing your contact details with the study coordinator.