Camel's Milk as a Safe Alternative in Cow's Milk Allergy
This study is currently recruiting participants.
Verified August 2012 by Meir Medical Center
Sponsor:
Meir Medical Center
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01223885
First received: October 10, 2010
Last updated: August 9, 2012
Last verified: August 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 10, 2010 | ||||
| Last Updated Date | August 9, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Development of allergic symptoms after graded oral challenge with camel's milk [ Time Frame: 3 hours follow-up after completion of the challenge ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01223885 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Camel's Milk as a Safe Alternative in Cow's Milk Allergy | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cow's Milk Allergy | ||||
| Intervention ICMJE | Dietary Supplement: Camel's milk
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 |
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| Study Arm (s) | Experimental: Camel's milk, Cow's milk allergy
Intervention: Dietary Supplement: Camel's milk |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01223885 | ||||
| Other Study ID Numbers ICMJE | CM-MK-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Meir Medical Center | ||||
| Study Sponsor ICMJE | Meir Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Meir Medical Center | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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