Clinical Trials Logo

Clinical Trial Summary

The goal of this study will be to increase the reaction threshold (desensitization) of peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance).


Clinical Trial Description

Allergy to peanuts and tree nuts affects approximately 1.4% of the population. Allergic reactions to peanut can be severe and life threatening and account for the vast majority of fatalities due to food-induced anaphylaxis. At present, there are no viable treatment options for patients with peanut allergy. The current standard of care is strict dietary elimination and emergency preparedness with an anaphylaxis kit in the event of an accidental reaction.

Our group and others have shown that oral immunotherapy can provide protection from anaphylaxis to a variety of food proteins. In addition, our ongoing research has demonstrated that sublingual immunotherapy to peanut provides a safe, alternative mode of immunotherapy to reduce allergic reaction rates (desensitization) during oral food challenge (OFC) to peanut. The goal of this study will be to desensitize peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance). Children ages 1-11 years will be enrolled following an entry double blind, placebo controlled food challenge (DBPCFC).

After at least 48 months of peanut SLIT study drug, subjects will undergo a second DBPCFC to 5000 mg of peanut protein to assess desensitization.

- Subjects who are not desensitized are those who are not able to consume more than the MCRT without symptoms, which has been defined as 300 mg of peanut protein. Subjects who consume less than 300 mg of peanut protein without symptoms will stop peanut SLIT and conclude the study. These subjects will not undergo any additional study procedures including the remaining protocol DBPCFCs and will be recommended to resume a strict peanut avoidance diet.

- Subjects who are able to consume more than 300 mg of peanut protein will be randomized to an interval between 1 and 17 weeks during which all peanut including peanut SLIT study drug will be discontinued. This period of avoidance will be followed by a third DBPCFC to 5000 mg of peanut protein to evaluate for the loss of the desensitization effect. After this final DBPCFC, the study will be completed for these subjects. At the primary investigators clinical discretion, they will be recommended to transition to a daily peanut food equivalent to maintain the desensitized effect.

Outcome variables of interest include response to double blind, placebo controlled food challenges, skin prick testing, peanut specific serum immunoglobin E (IgE), immunoglobin G (IgG), and immunoglobin G4 (IgG4) and salivary immunoglobin A (IgA), T and B cell responses, basophil hyporesponsiveness, quality of life, and adverse events. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01373242
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 2011
Completion date April 16, 2018

See also
  Status Clinical Trial Phase
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05839405 - Food Allergy in the Brain
Completed NCT02552537 - iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions Phase 4
Completed NCT01634737 - Crustacean Allergy and Dust Mites Sensitization N/A
Recruiting NCT05521711 - TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation N/A
Completed NCT05072665 - Fast Allergy Sensitivity Test N/A
Active, not recruiting NCT04887441 - Allergology: Information, Data and Knowledge Organization
Recruiting NCT03265262 - The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy N/A
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02490007 - Pertussis Immunisation and Food Allergy
Recruiting NCT03151252 - Improvement of Foodallergy Diagnostic in Gastrointestinal Tract N/A
Completed NCT02159833 - Intranasal Diagnostics in Food Allergy: a Feasibility Study N/A
Completed NCT02354729 - Encouraging Allergic Young Adults to Carry Epinephrine N/A
Completed NCT02377284 - Prevention and Management of Food Allergies N/A
Completed NCT02640560 - One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish N/A
Enrolling by invitation NCT06097572 - Improved Diagnostics in Food Allergy Study N/A
Recruiting NCT04606615 - Skin Barrier Abnormalities and Oxidative Stress Response
Recruiting NCT05785299 - Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy N/A
Not yet recruiting NCT06112873 - Quality of Life in Food Allergy: Validation of Three Mini-questionnaires
Completed NCT03337802 - Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring N/A