BridgeMD
Tests treatment safety and results for Peanut Allergy
Official title Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
ClinicalTrials.gov ID: NCT06256146
What this study is testing
- What it's testing
- Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 40
You may be able to join if
- A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined...
- The presence of at least one of the following confirmatory tests:
- Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial...
- Detection of serum specific IgE (\>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP...
You likely can't join if
- Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
- Patients who present with intercurrent disease active at the time of starting desensitization.
- Non IgE mediated or non-immunological adverse reactions to milk or peanuts.
- Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- Patients receiving oral immunosuppressor therapy.
- Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.
See the full eligibility criteria
- A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe...
- The presence of at least one of the following confirmatory tests:
- Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario).
- Detection of serum specific IgE (\>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).
- Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
- Patients who present with intercurrent disease active at the time of starting desensitization.
- Non IgE mediated or non-immunological adverse reactions to milk or peanuts.
- Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- Patients receiving oral immunosuppressor therapy.
- Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.
- Associated diseases contraindicating the use of epinephrine: cardiovascular disease, severe hypertension or hypotension.
- Patients diagnosed with eosinophilic gastrointestinal disorders, including patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm.
- Patients already tolerating processed/cooked forms of the food (e.g.,baked goods with milk).
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.