High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
Primary Purpose
Peanut Allergy
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
High dose of peanuts
Low dose of peanuts
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring peanuts, food allergy, immunotherapy, children
Eligibility Criteria
Inclusion Criteria:
- medical history of peanut allergy,
- IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),
- reaction to less than 100 mg of peanut protein during OOFC,
- signed Informed Consent by parent/legal guardian and patient aged >16 years old,
- patient's/caregivers' cooperation with researcher.
Exclusion Criteria:
- no confirmed peanut allergy,
- negative oral food challenge with less than 100mg of peanut protein,
- severe asthma,
- uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5. percentile), FEV1/forced vital capacity (FVC)<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
- current oral/sublingual/subcutaneous immunotherapy with other allergen,
- eosinophilic gastroenteritis,
- a history of severe recurrent anaphylaxis episodes,
- chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
medication:
- oral, daily steroid therapy longer than 1 month within last 12 months,
- at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
- oral steroid therapy longer than 7 days within last 3 months,
- biological treatment,
- the need to constantly take antihistamines,
- therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,
- pregnancy,
- no consent to participate in the study,
- lack of patient cooperation.
Sites / Locations
- Department of Pediatric Pneumonology and Allergy, Medical University of WarsawRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high dose of peanut
low dose of peanuts
Arm Description
20 patients
20 patients
Outcomes
Primary Outcome Measures
Tolerance of peanuts
Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein
Secondary Outcome Measures
Adverse event
quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category
Laboratory data
difference in peanut serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment
Skin prick test (SPT)
change in skin prick test reactivity to peanut protein from baseline to end of treatment, compared between groups
Full Information
NCT ID
NCT04415593
First Posted
April 20, 2020
Last Updated
April 12, 2021
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT04415593
Brief Title
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
Official Title
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.
Detailed Description
Peanut allergy is a significant clinical problem. Food immunotherapy provides the latest approach to managing food allergy. Oral immunotherapy is considered as the most effective and safe, according to current research. What is more, this type of therapy is easily available and can be continued at patient's home. Obtaining and maintenance of tolerance to the allergic food is the main goal of this procedure.
The study will include children with peanut allergy, confirmed during open oral food challenge (OOFC) with peanut protein. First OOFC will be performed before immunotherapy, second one at the end of procedure. Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low and high dose of peanut protein in children randomly assigned to two groups (1:1).
In the following phase, every two weeks the dose of ground roasted peanut will be increased and applied to a child during hospitalization (1-day procedure). Precondition to increase of dose is good tolerance of previous portion of peanut. The maximum time frame for this phase is 14 months.
After achieving tolerance, immunotherapy will be continued for 2 months in maintenance phase, with dose 150mg or 300 mg peanut protein, depending on a study group.
The dosage increasing phase will last maximally 14 months. If patients achieves the maintenance dose earlier, this period may be shorter. Maintenance dose is determined by random patients' assignment to one from study's group and amounts 150mg or 300 mg of peanut protein, respectively.
The duration of the maintenance phase is 8 weeks (+/-2 weeks). After 2 months (8 weeks +/-2 weeks) of maintenance dose the final OOFC and evaluation of tolerance of peanut protein will be performed. Confirmation of the total desensitization of peanut is the tolerance of a single dose of 4500 mg peanut protein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
peanuts, food allergy, immunotherapy, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low (150mg) and high (300mg) dose of peanut protein in children randomly assigned to two groups (1:1).
Patients will receive ground peanuts mixed with apple mousse (supposing apple tolerance). For the transparency of the study all patients will receive the same commercially prepared apple muss product.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high dose of peanut
Arm Type
Experimental
Arm Description
20 patients
Arm Title
low dose of peanuts
Arm Type
Active Comparator
Arm Description
20 patients
Intervention Type
Dietary Supplement
Intervention Name(s)
High dose of peanuts
Intervention Description
Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
Intervention Type
Dietary Supplement
Intervention Name(s)
Low dose of peanuts
Intervention Description
Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
Primary Outcome Measure Information:
Title
Tolerance of peanuts
Description
Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein
Time Frame
Up to 16 months after starting oral immunotherapy
Secondary Outcome Measure Information:
Title
Adverse event
Description
quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category
Time Frame
Up to 16 months after starting oral immunotherapy
Title
Laboratory data
Description
difference in peanut serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment
Time Frame
Up to 16 months after starting oral immunotherapy
Title
Skin prick test (SPT)
Description
change in skin prick test reactivity to peanut protein from baseline to end of treatment, compared between groups
Time Frame
Up to 16 months after starting oral immunotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medical history of peanut allergy,
IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),
reaction to less than 100 mg of peanut protein during OOFC,
signed Informed Consent by parent/legal guardian and patient aged >16 years old,
patient's/caregivers' cooperation with researcher.
Exclusion Criteria:
no confirmed peanut allergy,
negative oral food challenge with less than 100mg of peanut protein,
severe asthma,
uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5. percentile), FEV1/forced vital capacity (FVC)<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
current oral/sublingual/subcutaneous immunotherapy with other allergen,
eosinophilic gastroenteritis,
a history of severe recurrent anaphylaxis episodes,
chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
medication:
oral, daily steroid therapy longer than 1 month within last 12 months,
at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
oral steroid therapy longer than 7 days within last 3 months,
biological treatment,
the need to constantly take antihistamines,
therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,
pregnancy,
no consent to participate in the study,
lack of patient cooperation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wioletta Zagórska, PhD, MD
Phone
+48 22 3179431
Email
wiola.zagorska@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Grzela, PhD, MD
Phone
+48 22 3179431
Email
kgrzela@wum.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klementyna Łyżwa, MD
Organizational Affiliation
Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wioetta Zagórska, PhD, MD
Phone
+48 22 317 9431
Email
wiola.zagorska@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
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