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

NCT02216175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-01-18

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • JP Moulton Charitable Foundation

    collaborator OTHER

  • Sociedad Española de Alergología e Inmunología

    collaborator UNKNOWN

  • Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-19
Primary Completion
2021-09-30
Completion
2022-01-19

Countries

  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216175 on ClinicalTrials.gov