Study Stopped
Concern for cross contamination in weighing tree nuts in facility with peanuts
Walnut Oral Immunotherapy for Tree Nut Allergy
WOIT
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 12, 2013
Actual (reported)April 17, 2013
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 2013
Actual (reported)December 2013
Actual (reported)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
Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study
38 weeks
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.
38 weeks
The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut.
36 months
Increase in walnut and test tree nut IgG4 over the course of the study.
36 months
Decrease in the walnut and test tree nut specific IgE over the course of the study.
36 months
Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose.
Oat flour administered in identical increasing amounts as the active walnut protein flour.
Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut.
Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment.
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.
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.
Wesley Burks, MD
UNC Chapel Hill
Edwin Kim, MD
UNC Chapel Hill
0 participants (actual enrollment reported by the registry).
First Submitted
April 12, 2013
First Posted
April 17, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Tolerance Following Peanut Oral Immunotherapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
June 17, 2016
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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