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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2022-01-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Food Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SLIT followed by Conventional OIT

Participants will receive up to 7 months of SLIT followed by 6 months conventional OIT to cow's milk

Group Type EXPERIMENTAL

SLIT to cow's milk

Intervention Type OTHER

Sublingual immunotherapy

Conventional OIT to cow's milk

Intervention Type OTHER

Oral Immunotherapy

Conventional OIT

Participants will receive up to 7 months of low dose OIT, followed by 6 months conventional OIT to cow's milk

Group Type ACTIVE_COMPARATOR

Low dose OIT

Intervention Type OTHER

Oral Immunotherapy (low dose)

Conventional OIT to cow's milk

Intervention Type OTHER

Oral Immunotherapy

Delayed start OIT

Participants will receive up to 7 months placebo, followed by 6 months conventional OIT to cow's milk

Group Type PLACEBO_COMPARATOR

Conventional OIT to cow's milk

Intervention Type OTHER

Oral Immunotherapy

Interventions

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SLIT to cow's milk

Sublingual immunotherapy

Intervention Type OTHER

Low dose OIT

Oral Immunotherapy (low dose)

Intervention Type OTHER

Conventional OIT to cow's milk

Oral Immunotherapy

Intervention Type OTHER

Eligibility Criteria

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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.
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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No