Camel's Milk as a Safe Alternative in Cow's Milk Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01223885
First received: October 10, 2010
Last updated: October 7, 2015
Last verified: August 2012
  Purpose
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.

Condition Intervention
Cow's Milk Allergy
Dietary Supplement: Camel's milk

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Camel's milk, Cow's milk allergy 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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Proved cow"s milk allergy

Exclusion Criteria:

  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223885

Locations
Israel
Allergy Unit, Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01223885     History of Changes
Other Study ID Numbers: CM-MK-2 
Study First Received: October 10, 2010
Last Updated: October 7, 2015
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 28, 2016