Back to resultsEarly Oral Immunotherapy in Infants With Cow's Milk Protein Allergy
Primary Purpose
Hypersensitivity, Milk
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Oral immunotherapy protocol
Sponsored by
About this trial
This is an interventional treatment trial for Hypersensitivity, Milk focused on measuring Hypersensitivity, Milk, Cow's Milk, Immunotherapy, Infant
Eligibility Criteria
Inclusion Criteria:
• children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)
Exclusion Criteria:
- children with not IgE-mediated clinical manifestations
- children with a known immunodeficiency
Sites / Locations
- Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral immunotherapy protocol
Arm Description
Eligible children receive the oral food challenge (OCD) protocol
Outcomes
Primary Outcome Measures
number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products
Secondary Outcome Measures
Clinical reactions experienced by children at home
Number and types, communicated by parents at a dedicated telephone number.
Serum levels of specific IgE
Comparison in serum levels of specific IgE between baseline and the end of the protocol, hypothesizing a decrease of IgE levels after OFC
Serum levels of specific IgG4
Comparison in serum levels of specific IgG4 between baseline and the end of the protocol, hypothesizing an increase of IgG4 levels after OFC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03586388
Brief Title
Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy
Official Title
Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.
The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions.
Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited.
The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity, Milk
Keywords
Hypersensitivity, Milk, Cow's Milk, Immunotherapy, Infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral immunotherapy protocol
Arm Type
Experimental
Arm Description
Eligible children receive the oral food challenge (OCD) protocol
Intervention Type
Other
Intervention Name(s)
Oral immunotherapy protocol
Other Intervention Name(s)
Oral food challenge (OCD)
Intervention Description
In hospital setting: three increasing doses every 30 minutes of 1ml, 5ml and 10ml of cow milk (CM). Oral food challenge (OFC) stopped at 10ml even if no clinical reactions occurred.
At home: every child will take the dose tolerated in hospital, starting the day after the OFC, for 3-4 weeks.Once reached the dose of 40ml of CM without reactions for at least 2 weeks, families increment the dose of 5 ml every week, till the tolerance of 50 ml, then of 10 ml every week, till the tolerance of 100ml and then, of 10 ml every 3 days till the tolerance of 150 ml of milk.
Primary Outcome Measure Information:
Title
number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
Description
Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical reactions experienced by children at home
Description
Number and types, communicated by parents at a dedicated telephone number.
Time Frame
6 months
Title
Serum levels of specific IgE
Description
Comparison in serum levels of specific IgE between baseline and the end of the protocol, hypothesizing a decrease of IgE levels after OFC
Time Frame
6 months
Title
Serum levels of specific IgG4
Description
Comparison in serum levels of specific IgG4 between baseline and the end of the protocol, hypothesizing an increase of IgG4 levels after OFC
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)
Exclusion Criteria:
children with not IgE-mediated clinical manifestations
children with a known immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Badina, Md
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giorgio Longo, MD
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Egidio Barbi, MD
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Study Director
Facility Information:
Facility Name
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
City
Trieste
ZIP/Postal Code
34137
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy
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