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D021183: Peanut Hypersensitivity

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug1844 Liquid Peanut Extract Wiki 1.00
drug2525 Placebo Glycerin SLIT Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D005512 Food Hypersensitivity NIH 1.00
D006967 Hypersensitivity, NIH 0.45

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0012393 Allergy HPO 0.45

Clinical Trials

Navigate: Correlations   HPO

There is one clinical trial.


1 Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children

Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. [Time Frame: Baseline, 36 months] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4 response, 2) peanut specific basophil activation, 3) mast cell responses through skin prick testing, and 4) specific T-cell cytokine responses and T regulatory cell (TReg) activation. The investigators anticipate that the effect of peanut SLIT will occur by induction of TRegs, conversion of T cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response (measured by cytokines, antibody levels, and skin prick test size), a change in peanut-specific basophil activation, or through a combination of the above. [Time Frame: Baseline, 39 months]

NCT02304991
Conditions
  1. Peanut Hypersensitivity
  2. Food Allergy
  3. Food Hypersensitivity
  4. Peanut Allergy
Interventions
  1. Drug: Liquid Peanut Extract
  2. Drug: Placebo Glycerin SLIT
MeSH:Hypersensitivity Food Hypersensitivity Peanut Hypersensitivity
HPO:Allergy

Primary Outcomes

Description: The primary outcome is to detect a statistically significant difference in reaction thresholds to peanut between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. The difference is measured through utilization of an extreme value hazard function.

Measure: Percentage of participants desensitized to peanut using peanut SLIT as an early intervention in subjects ages 1 to 4 years

Time: From baseline to 36 months

Secondary Outcomes

Description: Detect a statistically significant difference between reaction thresholds to peanut of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).

Measure: Statistically significant difference in the challenge scores of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance)

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific IgE levels

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific IgG levels

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific IgG4 levels

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific basophil activation

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in responses of mast cell as measured by prick skin testing to peanut

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in specific T-cell cytokine responses

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in T regulatory cell activation

Time: From baseline to 39 months

Description: Incidence of all serious adverse events during the study

Measure: Incidence of all serious adverse events during the study

Time: From baseline to 39 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


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Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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