Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy

Study Purpose

Allergy to cow's milk is the most common food allergy affecting children. There is currently no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to induce desensitisation using small daily doses of cow's milk, predominantly by the oral route (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not generally long lasting and it is associated with significant side effects during protocol, including potentially life-threatening allergic reactions. Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer adverse events. However, the degree of desensitisation induced appears to be lower than that with oral immunotherapy. The investigators wish to determine whether a sublingual pretreatment phase can improve the safety of conventional OIT in cow's milk allergy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	6 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: 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.	NCT02216175
Phase 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.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Spain, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Arms & Interventions

Arms

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

Interventions

Other: - SLIT to cow's milk

Sublingual immunotherapy

Other: - Low dose OIT

Oral Immunotherapy (low dose)

Other: - Conventional OIT to cow's milk

Oral Immunotherapy

Contact a Trial Team

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International Sites

Niño Jesús Hospital, Madrid, Spain

Status

Address

Niño Jesús Hospital

Madrid, ,

London, United Kingdom

Status

Address

Imperial College London / Imperial College Healthcare NHS Trust

London, ,

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