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Oral Immunotherapy for Peanut and Mammalian Meat Allergies

NCT ID: NCT02350660

Last Updated: 2020-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-06-30

Brief Summary

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Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.

Detailed Description

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In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies.

Conditions

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Food Hypersensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cow's milk for alpha-gal allergics

daily consumption of cow's milk

Group Type EXPERIMENTAL

cow's milk

Intervention Type DIETARY_SUPPLEMENT

daily consumption of cow's milk

Peanut powder

peanut oral immunotherapy

Group Type EXPERIMENTAL

peanut powder

Intervention Type DIETARY_SUPPLEMENT

peanut oral immunotherapy

Interventions

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cow's milk

daily consumption of cow's milk

Intervention Type DIETARY_SUPPLEMENT

peanut powder

peanut oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Presence or absence of specific IgE to alpha-gal or peanut

Exclusion Criteria

* History of severe anaphylaxis
* allergy to cow's milk protein
Minimum Eligible Age

4 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Scott Commins, MD

Associate Professor, Department of Medicine, Allergy and Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Commins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Wisniewski JA, Commins SP, Agrawal R, Hulse KE, Yu MD, Cronin J, Heymann PW, Pomes A, Platts-Mills TA, Workman L, Woodfolk JA. Analysis of cytokine production by peanut-reactive T cells identifies residual Th2 effectors in highly allergic children who received peanut oral immunotherapy. Clin Exp Allergy. 2015 Jul;45(7):1201-13. doi: 10.1111/cea.12537.

Reference Type DERIVED
PMID: 25823600 (View on PubMed)

Other Identifiers

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15098

Identifier Type: -

Identifier Source: org_study_id