Cow's Milk AllergyNCT01223885
Camel's Milk as a Safe Alternative in Cow's Milk Allergy
A study testing Camel's milk in people with Cow's Milk Allergy, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Camel's milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Proved cow"s milk allergy
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cow's Milk Allergy
- Being tested
- Camel's milk
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camel's milkDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Camel's milk, Cow's milk allergy | Experimental | Not described Receives: Dietary Supplement: Camel's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of allergic symptoms after graded oral challenge with camel's milk
Measured: 3 hours follow-up after completion of the challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223885
- Sponsor's protocol ID
- CM-MK-2
- Status last verified
- Aug 2012
- First submitted
- 10 Oct 2010
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camel's Milk as a Safe Alternative in Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT01223885
- Acronym / sponsor ID
- CM-MK-2
- Conditions
- Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camel's milk, Cow's milk allergy | Experimental | Dietary Supplement: Camel's milk |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Proved cow"s milk allergy
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camel's milkPatients 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 | Dietary supplement | Camel's milk, Cow's milk allergy |
Primary outcome
Development of allergic symptoms after graded oral challenge with camel's milk
Time frame: 3 hours follow-up after completion of the challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
Related trials for Cow's Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camel's milk in people with Cow's Milk Allergy, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of allergic symptoms after graded oral challenge with camel's milk (time frame: 3 hours follow-up after completion of the challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.