Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 17 Years|
Inclusion Criteria:1. Allergic to 1.44g CM protein (approx. 40ml fresh milk) or less, at DBPCFC prior to randomisation 2. Informed consent of parent/legal guardian, patient assent where possible
Exclusion Criteria:1. Required previous admission to an intensive care unit for management of an allergic reaction. 2. Significant symptoms of non--‐IgE--‐mediated CM allergy within the previous 12 months. 3. Children with a past history of CM allergy currently consuming CM‐containing products other than extensively--heated milk in baked foods (e.g. biscuits, cakes). 4. Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months. 5. Moderate--‐severe eczema, defined as requiring more than once daily application of 1% hydrocortisone as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria) 6. Clinically significant chronic illness (other than asthma, rhinitis or eczema) 7. History of symptoms of eosinophilic oesophagitis, irrespective of cause 8. Undergoing specific immunotherapy to another allergen and within the first year of treatment. 9. Receiving anti--IgE therapy, oral immunosuppressants, beta--‐blocker or ACE inhibitor. 10. Pregnancy 11. Unwilling or unable to fulfil study requirements
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Imperial College London|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Spain, United Kingdom|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: SLIT followed by Conventional OIT
Participants will receive up to 7 months of SLIT followed by 6 months conventional OIT to cow's milk
Active Comparator: Conventional OIT
Participants will receive up to 7 months of low dose OIT, followed by 6 months conventional OIT to cow's milk
Placebo Comparator: Delayed start OIT
Participants will receive up to 7 months placebo, followed by 6 months conventional OIT to cow's milk
Other: - SLIT to cow's milk
Other: - Low dose OIT
Oral Immunotherapy (low dose)
Other: - Conventional OIT to cow's milk
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.