Not provided
Not provided
Not provided
Not provided
Not provided
Concern for cross contamination in weighing tree nuts in facility with peanuts
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their immune system.
Tree nut
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walnut protein flour | Active Comparator | Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose. |
|
| Oat flour | Placebo Comparator | Oat flour administered in identical increasing amounts as the active walnut protein flour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walnut Protein Flour | Drug | Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut. | The determination of the effectiveness of WOIT in inducing clinical desensitization to a second tree nut to which the subject is allergic when compared to placebo. This will be measured by the change in the amount of tree nut the subject can consume during their food challenge at 38 weeks compared to their consumption during the baseline challenge at study entry. | 38 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study | The percentage of subjects who can consume all of the 5000mg of walnut protein without symptoms during the food challenge after the desensitization phase of the study. | 38 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in walnut and test tree nut IgG4 over the course of the study. | The increase in the walnut and test tree nut specific IgG4 over the course of the study as an indication of the impact of WOIT on the immune system. | 36 months |
| Decrease in the walnut and test tree nut specific IgE over the course of the study. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | UNC Chapel Hill | Principal Investigator |
| Edwin Kim, MD | UNC Chapel Hill | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21093029 | Background | Kulis M, Li Y, Lane H, Pons L, Burks W. Single-tree nut immunotherapy attenuates allergic reactions in mice with hypersensitivity to multiple tree nuts. J Allergy Clin Immunol. 2011 Jan;127(1):81-8. doi: 10.1016/j.jaci.2010.09.014. Epub 2010 Nov 18. | |
| 19477496 | Background | Hofmann AM, Scurlock AM, Jones SM, Palmer KP, Lokhnygina Y, Steele PH, Kamilaris J, Burks AW. Safety of a peanut oral immunotherapy protocol in children with peanut allergy. J Allergy Clin Immunol. 2009 Aug;124(2):286-91, 291.e1-6. doi: 10.1016/j.jaci.2009.03.045. Epub 2009 May 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D021184 | Nut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Oat flour | Drug | Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment. |
|
|
| The percentage of subjects who are able to reach a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut. |
The percentage of subjects who are able to consume a cumulative protein dose of 2000 mg of walnut and test tree nut without symptoms during the desensitization oral food challenge. |
| 38 weeks |
| The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut. | The percentage of subjects who are able to demonstrate clinical tolerance by consuming all of the walnut and test tree nut without symptoms during the oral food challenge at the end of the study. | 36 months |
The decrease in the walnut and test tree nut specific IgE over the course of the study as an indication of the impact of WOIT on the immune system. |
| 36 months |
| 19577283 | Background | Jones SM, Pons L, Roberts JL, Scurlock AM, Perry TT, Kulis M, Shreffler WG, Steele P, Henry KA, Adair M, Francis JM, Durham S, Vickery BP, Zhong X, Burks AW. Clinical efficacy and immune regulation with peanut oral immunotherapy. J Allergy Clin Immunol. 2009 Aug;124(2):292-300, 300.e1-97. doi: 10.1016/j.jaci.2009.05.022. Epub 2009 Jul 3. |
| 21377034 | Background | Varshney P, Jones SM, Scurlock AM, Perry TT, Kemper A, Steele P, Hiegel A, Kamilaris J, Carlisle S, Yue X, Kulis M, Pons L, Vickery B, Burks AW. A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response. J Allergy Clin Immunol. 2011 Mar;127(3):654-60. doi: 10.1016/j.jaci.2010.12.1111. |
| D007154 | Immune System Diseases |