Food Hypersensitivity
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTcow's milk
daily consumption of cow's milk
DIETARY_SUPPLEMENTpeanut powder
peanut oral immunotherapy
Sponsors
University of Virginia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Level of Allergen Consumed Post-oral Immunotherapy | Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37 | consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly. |
Countries
United States
Participant flow
Pre-assignment details
Due to changes in funding structure, the study was unable to be completed with the designed number of participants and was therefore closed to enrollment
Participants by arm
| Arm | Count |
|---|---|
| Cow's Milk for Alpha-gal Allergics daily consumption of cow's milk
cow's milk: daily consumption of cow's milk | 7 |
| Peanut Powder peanut oral immunotherapy
peanut powder: peanut oral immunotherapy | 17 |
| Total | 24 |
Baseline characteristics
| Characteristic | Peanut Powder | Cow's Milk for Alpha-gal Allergics | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 0 Participants | 16 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 6 Participants | 7 Participants |
| Age, Continuous | 8 years STANDARD_DEVIATION 3 | 55 years STANDARD_DEVIATION 7 | 23 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 17 participants | 7 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 3 / 17 |
| serious Total, serious adverse events | 0 / 7 | 0 / 17 |
Outcome results
Primary
The Level of Allergen Consumed Post-oral Immunotherapy
consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly.
Time frame: Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cow's Milk for Alpha-gal Allergics | The Level of Allergen Consumed Post-oral Immunotherapy | 6 milligrams | Standard Deviation 1.3 |
| Peanut Powder | The Level of Allergen Consumed Post-oral Immunotherapy | 300 milligrams | Standard Deviation 57 |