A Phase 1/2 interventional study of Walnut Protein Flour and Oat flour in Nut Hypersensitivities, sponsored by University of North Carolina, Chapel Hill. Withdrawn. Open to participants aged 6 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-06-17.
Sponsored by University of North Carolina, Chapel Hill · Phase 1/2, Interventional, and Treatment
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
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
Browse Nut Hypersensitivity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose.
Drug: Walnut Protein Flour
Oat flour administered in identical increasing amounts as the active walnut protein flour.
Drug: Oat flour
Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut.
Also known as: Walnut OIT
Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment.
Also known as: Placebo
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.
Time frame: 38 weeks
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 36 months
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.
Time frame: 36 months
Decrease in the walnut and test tree nut specific IgE over the course of the study.
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.
Time frame: 36 months
No study locations are listed for this record.
Plan to share: No
The record gives a start of Nov 2013, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →