Food Allergy Clinical Trial
— FARE/SLITOfficial title:
Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children
Verified date | January 2021 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. [Time Frame: Baseline, 39 months]
Status | Completed |
Enrollment | 50 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 48 Months |
Eligibility | Inclusion Criteria: - Written informed consent from participant's parent/guardian. - Age 12-48 months of either sex, any race, any ethnicity. - A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a serum peanut-specific IgE [UniCAP] > 0.35 kUA/L AND a positive skin prick test to peanut (>3 mm than the negative control) OR are sensitized to peanut (based on a serum IgE [UniCAP] to peanut of > 5 kUA/L) AND a positive skin prick test to peanut (> 3 mm than the negative control) and no known history of ingestion of peanut. - A positive DBPCFC to 1000 mg of peanut at enrollment. Exclusion Criteria: - History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or peripheral capillary oxygen saturation (SpO2) < 92% at any stage, hypotension, confusion, collapse or loss of consciousness). - Participation in any interventional study for the treatment of food allergy in the past 6 months. - Known oat, wheat, or glycerin allergy. - Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease. - Severe asthma (2007 NHLBI Criteria Steps 5 or 6 - Appendix 2). - Inability to discontinue antihistamines for skin testing and DBPCFCs. - Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year. - Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers. - Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Food Allergy Research & Education, National Center for Complementary and Integrative Health (NCCIH), University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Desensitization After 36 Months of Peanut SLIT or Placebo SLIT | The primary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during DBPCFC after 36 months of peanut SLIT (desensitization).
DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7. |
36 months | |
Secondary | Tolerance 3 Months After Discontinuing Peanut SLIT or Placebo SLIT | A secondary outcome of this study 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).
DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7. |
39 months | |
Secondary | Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgE) | The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization.
Peanut-specific IgE measured at baseline and at completion of peanut SLIT (36 months). Change in IgE reported in kUA/L. |
0 months to 36 months | |
Secondary | Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgG4) | The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization.
Peanut-specific IgG4 measured at baseline and at completion of peanut SLIT (36 months). Change in IgG4 reported in mg/L. |
0 months to 36 months | |
Secondary | Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut Skin Prick Test) | The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization.
Peanut-skin prick test measured at baseline and at completion of peanut SLIT (36 months). Change in skin prick test reported in mm wheal diameter. |
0 months to 36 months | |
Secondary | Number of Participants Experiencing Serious Adverse Events With Peanut SLIT Versus Placebo SLIT | Incidence of all serious adverse events from initial enrollment through the end of the 3 month avoidance period reported as the number of participants experiencing a serious adverse event. | 39 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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