Food HypersensitivityNCT02350660
Oral Immunotherapy for Peanut and Mammalian Meat Allergies
A study testing cow's milk and peanut powder in people with Food Hypersensitivity, run by University of Virginia at 1 site in United States.
Trial summary
Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies. Read more about this study
- Who is it for?
- Ages 4 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- cow's milk and peanut powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Presence or absence of specific IgE to alpha-gal or peanut
Who cannot join
- History of severe anaphylaxis
- allergy to cow's milk protein
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.
Read the 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.
- Conditions
- Food Hypersensitivity
- Being tested
- cow's milk, peanut powder
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cow's milkDietary supplement
daily consumption of cow's milk
peanut powderDietary supplement
peanut oral immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk for alpha-gal allergics | Experimental | daily consumption of cow's milk Receives: Dietary Supplement: cow's milk |
| Peanut powder | Experimental | peanut oral immunotherapy Receives: Dietary Supplement: peanut powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Commins, MD, University of Virginia
- Investigators
- Scott Commins, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350660
- Sponsor's protocol ID
- 15098
- Status last verified
- Nov 2020
- First submitted
- 21 Jan 2015
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25823600
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy for Peanut and Mammalian Meat Allergies
- ClinicalTrials.gov ID
- NCT02350660
- Acronym / sponsor ID
- 15098
- Conditions
- Food Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow's milk for alpha-gal allergics | Experimental | Dietary Supplement: cow's milkdaily consumption of cow's milk |
| Peanut powder | Experimental | Dietary Supplement: peanut powderpeanut oral immunotherapy |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence or absence of specific IgE to alpha-gal or peanut
Key exclusion criteria (2 listed)
- History of severe anaphylaxis
- allergy to cow's milk protein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cow's milkdaily consumption of cow's milk | Dietary supplement | Cow's milk for alpha-gal allergics |
| peanut powderpeanut oral immunotherapy | Dietary supplement | Peanut powder |
Primary outcome
The Level of Allergen Consumed Post-oral Immunotherapy
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25823600Wisniewski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Commins, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cow's milk and peanut powder in people with Food Hypersensitivity, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Level of Allergen Consumed Post-oral Immunotherapy (time frame: Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.