Camel's Milk as a Safe Alternative in Cow's Milk Allergy
Primary Purpose
Cow's Milk Allergy
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Camel's milk
Sponsored by
About this trial
This is an interventional treatment trial for Cow's Milk Allergy
Eligibility Criteria
Inclusion Criteria:
- Proved cow"s milk allergy
Exclusion Criteria:
- Pregnant women
Sites / Locations
- Allergy Unit, Meir Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camel's milk, Cow's milk allergy
Arm Description
Outcomes
Primary Outcome Measures
Development of allergic symptoms after graded oral challenge with camel's milk
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01223885
Brief Title
Camel's Milk as a Safe Alternative in Cow's Milk Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
By performing a challenge with camel's milk in patients who are allergic to cow's milk, the investigators will examine if camel's milk is a safe alternative for these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camel's milk, Cow's milk allergy
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Camel's milk
Intervention Description
Patients with proved cow's milk allergy who have negative prick skin tests to came's milk will be administered gradually increased doses of pasteurized camel's milk at 30 minute intervals
Primary Outcome Measure Information:
Title
Development of allergic symptoms after graded oral challenge with camel's milk
Time Frame
3 hours follow-up after completion of the challenge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Proved cow"s milk allergy
Exclusion Criteria:
Pregnant women
Facility Information:
Facility Name
Allergy Unit, Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Camel's Milk as a Safe Alternative in Cow's Milk Allergy
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